Trial Outcomes & Findings for Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma (NCT NCT02794883)
NCT ID: NCT02794883
Last Updated: 2022-04-18
Results Overview
To determine the T-cell changes that occur in glioblastoma treated with tremelimumab and MEDI4736 as single agents and in combination. The changes from baseline will be assessed in blood samples and tissue samples before pre-surgery treatment with MEDI4736 and/or tremelimumab, day of surgery, and during adjuvant treatment, for all patients in the 3 arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From baseline up to end of treatment, where all patients received at least 1 dose pre-surgery, and range of cycles attempted post-surgery was 0-16 (1 Cycle = 4 weeks)
Results posted on
2022-04-18
Participant Flow
The study opened to accrual on September 13th, 2016 with an accrual goal of 36 patients. The first patient was enrolled onto the study and started treatment on November 1st, 2016. The accrual goal was met on April 5th, 2018. The study intended to increase the accrual goal, but the funding sponsor did not approve additional funding. The study closed permanently to further enrollment of participants on January 22nd, 2019.
Participant milestones
| Measure |
Arm 1: Tremelimumab Only
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Pre-Surgical Treatment
STARTED
|
12
|
12
|
12
|
|
Pre-Surgical Treatment
Registered for Study
|
12
|
12
|
12
|
|
Pre-Surgical Treatment
Received First Dose (Pre-surgical Dose) of Study Drug
|
12
|
11
|
11
|
|
Pre-Surgical Treatment
COMPLETED
|
12
|
11
|
11
|
|
Pre-Surgical Treatment
NOT COMPLETED
|
0
|
1
|
1
|
|
Post-Surgery Treatment (Adjuvant)
STARTED
|
12
|
11
|
11
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 1
|
11
|
8
|
11
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 2
|
7
|
8
|
11
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 3
|
3
|
7
|
4
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 4
|
2
|
5
|
2
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 5
|
2
|
3
|
2
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 6
|
0
|
3
|
2
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 7
|
0
|
3
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 8
|
0
|
3
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 9
|
0
|
3
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 10
|
0
|
2
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 11
|
0
|
2
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 12
|
0
|
1
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 13
|
0
|
1
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 14
|
0
|
1
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 15
|
0
|
0
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 16
|
0
|
0
|
1
|
|
Post-Surgery Treatment (Adjuvant)
Started Cycle 17
|
0
|
0
|
0
|
|
Post-Surgery Treatment (Adjuvant)
COMPLETED
|
0
|
0
|
0
|
|
Post-Surgery Treatment (Adjuvant)
NOT COMPLETED
|
12
|
11
|
11
|
|
Follow-up Period (up to 2 Years)
STARTED
|
12
|
11
|
11
|
|
Follow-up Period (up to 2 Years)
COMPLETED
|
0
|
1
|
1
|
|
Follow-up Period (up to 2 Years)
NOT COMPLETED
|
12
|
10
|
10
|
Reasons for withdrawal
| Measure |
Arm 1: Tremelimumab Only
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Pre-Surgical Treatment
Withdrawal by Subject
|
0
|
0
|
1
|
|
Pre-Surgical Treatment
Progressive Disease
|
0
|
1
|
0
|
|
Post-Surgery Treatment (Adjuvant)
Withdrawal by Subject
|
1
|
4
|
0
|
|
Post-Surgery Treatment (Adjuvant)
Protocol Violation
|
1
|
0
|
0
|
|
Post-Surgery Treatment (Adjuvant)
Progressive Disease
|
10
|
6
|
10
|
|
Post-Surgery Treatment (Adjuvant)
Adverse Event
|
0
|
1
|
1
|
|
Follow-up Period (up to 2 Years)
Death
|
12
|
10
|
10
|
Baseline Characteristics
Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma
Baseline characteristics by cohort
| Measure |
Arm 1: Tremelimumab Only
n=12 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=12 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=12 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline up to end of treatment, where all patients received at least 1 dose pre-surgery, and range of cycles attempted post-surgery was 0-16 (1 Cycle = 4 weeks)Population: Blood samples were collected from patients and shipped to an outside organization. The PI has contacted the outside organization to request T-cell data to be collected from blood samples and followed up multiple times. Outside organization has been unresponsive. There is no data collected from blood samples and will not be any data generated in the future from bloods samples for this endpoint. We have no data to report for this endpoint
To determine the T-cell changes that occur in glioblastoma treated with tremelimumab and MEDI4736 as single agents and in combination. The changes from baseline will be assessed in blood samples and tissue samples before pre-surgery treatment with MEDI4736 and/or tremelimumab, day of surgery, and during adjuvant treatment, for all patients in the 3 arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 days after surgeryTo assess MRI changes in lesion size in patients treated with either Tremelimumab or MEDI4736 alone and in combination of both post surgery. Only patients who have been administered at least one dose of investigational drug, undergone surgery, and have undergone at least one post-surgery disease assessment will be evaluable for this endpoint. Changes will be summarized using means. MRI changes below show the changes from baseline to after surgery.
Outcome measures
| Measure |
Arm 1: Tremelimumab Only
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=9 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
MRI Changes
|
1410 milimeters squared
Standard Deviation 4290
|
1720 milimeters squared
Standard Deviation 2730
|
3020 milimeters squared
Standard Deviation 7320
|
SECONDARY outcome
Timeframe: From baseline, pre-surgery treatment period (2 weeks prior to surgery), and post-surgery treatement, where the range of cycles attempted post-surgery was 0-16 (1 Cycle = 4 weeks), to 90 days post treatment discontinuationToxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs graded 3, 4, 5 (regardless of attribution to the study drug) are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.
Outcome measures
| Measure |
Arm 1: Tremelimumab Only
n=12 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 5 Disease Progression
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Left-sided Weakness
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 UTI
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Pulmonary Embolism
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 5 Intracranial hemorrhage
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 4 Seizures
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Seizures
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Viral meningitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Back Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Weakness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Encephalopathy
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Colitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Stroke
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Wound dehiscence
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Fall
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 4 Encephalopathy
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Clinical decline
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Acute Encephalopathy
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Intraparenchymal hemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Hydrocephalus
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Gait imbalance
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 4 Sepsis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Adverse Events Regardless of Attribution to the Study Drug Graded 3, 4, and 5
Grade 3 Wound Infection
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment (pre-surgery treatment period = 2 weeks), to surgery, to post-surgery treatment, where range of cycles attempted was 0-16 (1 Cycle = 4 weeks), to 2 years post treatment discontinuationTo determine post-surgery the overall survival for patients treated with Tremelimumab or MEDI4736 alone and in combination. This will be defined as the number of months surviving from the time of first dose of study treatment until death by any cause. Only patients who have been administered at least one dose of investigational drug and undergone surgery will be evaluable for this endpoint.
Outcome measures
| Measure |
Arm 1: Tremelimumab Only
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=9 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Overall Survival
|
7.246 months
Interval 2.746 to 16.32
|
11.71 months
Interval 8.332 to 32.71
|
7.703 months
Interval 7.411 to 40.14
|
SECONDARY outcome
Timeframe: From start of treatment (pre-surgery treatment period = 2 weeks), to surgery, to post-surgery treatment where range of cycles attempted was 0-16 (1 Cycle = 4 weeks), and up to 2 years of follow-up after treatment discontinuationTo the time to progression (per Modified RANO criteria and iRANO criteria) for patients treated with either Tremelimumab or MEDI4736 alone and in combination. This will be defined as the number of months from the time of first dose of study treatment until progression of disease (PD) or death from any cause. Only patients who have been administered at least one dose of investigational drug and undergone surgery will be evaluable for this endpoint. Definition of PD per RANO criteria: New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids; Increase by \> 50% (modified from \>25% according to published RANO criteria) enhancement from the first post-surgical scan, or a subsequent scan with smaller tumor size, and the scan 8 weeks or later on stable or increasing doses of corticosteroids; Clinical deterioration not attributable to concurrent medication or comorbid conditions.
Outcome measures
| Measure |
Arm 1: Tremelimumab Only
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=9 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=11 Participants
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Time to Progression
|
2.746 months
Interval 2.68 to 8.727
|
4.356 months
Interval 2.941 to 32.74
|
4.913 months
Interval 2.905 to 120.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsImmunologic changes of T-cells will be correlated to survival outcomes. T-cell changes will be measured from blood samples.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsImmunologic changes of PDL1 levels will be correlated to survival outcomes. PDL1 levels will be measured from blood samples.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Tremelimumab Only
Serious events: 9 serious events
Other events: 12 other events
Deaths: 12 deaths
Arm 2: MEDI4736 Only
Serious events: 10 serious events
Other events: 11 other events
Deaths: 10 deaths
Arm 3: Tremelimumab + MEDI4736
Serious events: 8 serious events
Other events: 11 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm 1: Tremelimumab Only
n=12 participants at risk
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=11 participants at risk；n=12 participants at risk
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=11 participants at risk；n=12 participants at risk
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Nervous system disorders
Seizures
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
41.7%
5/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Disease Progression
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
58.3%
7/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Left-sided weakness
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Urinary tract infection
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Vascular disorders
Pulmonary embolism
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Intracranial hemorrhage
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Encephalopathy
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Clinical decline
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Mental status change
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Viral meningitis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Weakness
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Intraparenchymal hemorrhage
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Gait imbalance
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Wound infection
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Stroke
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
Other adverse events
| Measure |
Arm 1: Tremelimumab Only
n=12 participants at risk
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg.
* Post-surgical MRI of brain will be done 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 5 mg, every 4 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks.
|
Arm 2: MEDI4736 Only
n=11 participants at risk；n=12 participants at risk
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): MEDI4736, 750 mg IV every 2 weeks for up to 24 months until disease progression or unacceptable toxicity.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
Arm 3: Tremelimumab + MEDI4736
n=11 participants at risk；n=12 participants at risk
* Pre-Surgery (14 days +/-3 days prior to surgery): One dose of tremelimumab IV, 75 mg, one dose of MEDI4736, 750 mg IV
* Post-surgical MRI of brain will be done within 72 hours after surgery.
* Post-Surgery (14 days after surgery): Tremelimumab IV, 75 mg, every 4 weeks (for up to 7 doses), MEDI4736 IV, 750 mg, every 2 weeks (for up to 14 doses).
* Starting C7D1 (week 25): Tremelimumab IV, 75 mg, every 12 weeks and MEDI4736 IV, 750mg, every 2 weeks, for up to 24 months until disease progression or unacceptable toxicity.
* On days when tremelimubab and MEDI4736 are given on the same day, tremilimumab is administered first, then MED14736 infused after a gap of 1 hour for the first cycle. If tolerated, then can be given one after the other for subsequent infusions.
* Contrast-enhanced MRI or CT scan will be done approximately every 2 cycles or 8 weeks
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
8/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
54.5%
6/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
81.8%
9/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
4/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
4/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
63.6%
7/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
63.6%
7/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
45.5%
5/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
45.5%
5/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
41.7%
5/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
45.5%
5/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
54.5%
6/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Mixed hyperlipidemia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Steroid myopathy
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain (intermittent)
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pseudomeningocele
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
epidural hematoma
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Amnesia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Ataxia
|
41.7%
5/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Concentration impairment
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Dysarthria
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Dysphasia
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Facial muscle weakness
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Headache
|
58.3%
7/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
63.6%
7/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Paraphasia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Memory impairment
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Sleep disturbance
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Expressive aphasia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Coma
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Disorientation
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Intermittent slurred speech
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Hemineglect
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Left sided hemiparesis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Proprioception difficulties
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Aphasia
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Intercranial edema
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Pronator drift
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Oculomotor nerve disorder
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Seizure
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Spasticity
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Confusion
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
45.5%
5/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Hallucinations
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Abulia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Anhedonia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Psychiatric disorders
Tearful
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Hematuria
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Nocturnal Urination
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Renal and urinary disorders
Urinary retention
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Oral mucositis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchitis
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Psoriatic flair
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Vascular disorders
Hypertension
|
91.7%
11/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
63.6%
7/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
72.7%
8/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Vascular disorders
Change in temperature
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Blood and lymphatic system disorders
Anemia
|
58.3%
7/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
81.8%
9/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
81.8%
9/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Blood and lymphatic system disorders
Blood and lymphatic disorders NOS
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Cardiac disorders
Palpatations
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
4/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
45.5%
5/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Endocrine disorders
Cushingoid
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Eye disorders
Blurred vision
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Eye disorders
Eyelid function disorder
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Eye disorders
Esotropia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Eye disorders
Ptosis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Eye disorders
Quadrantanopsia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
4/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Dry throat
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Fecal incontinence
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Chills
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Edema limbs
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Facial pain
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Fatigue
|
41.7%
5/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
63.6%
7/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Fever
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Gait disturbance
|
33.3%
4/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Irritability
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Localized edema
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Pain
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Facial droop
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Leg Swelling
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Transaminitis
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
General disorders
Infusion related reaction
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Oral thrush
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Staph infection
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Chest congestion
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
6/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
45.5%
5/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
27.3%
3/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Creatinine increased
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Fibrinoigen decreased
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
INR increased
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
8/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
72.7%
8/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
81.8%
9/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
54.5%
6/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
63.6%
7/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Weight gain
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
Weight loss
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Investigations
White blood cell decreased
|
16.7%
2/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
36.4%
4/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
18.2%
2/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
0.00%
0/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
91.7%
11/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
100.0%
11/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
90.9%
10/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.3%
1/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
3/12 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
9.1%
1/11 • Adverse Events (AEs) were collected over a 3 year period. For other AEs ,each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 90 days post last treatment. For Serious AEs, each patient was followed at time of consent and 90 days post last treatment. Patients received a single dose of study treatment pre-surgery. The range of adjuvant/post-surgery cycles attempted was 0-16 (1 cycle = 4 weeks).
All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
|
Additional Information
Karan Dixit, MD
Northwestern University, Feinberg School of Medicine
Phone: 312-503-4724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place