Trial Outcomes & Findings for PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation (NCT NCT01402063)
NCT ID: NCT01402063
Last Updated: 2020-02-17
Results Overview
MRI response evaluated by RANO criteria * Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. * Partial Response (PR): Decrease of \> 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan. * Progression (P): A \> 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Radiation Plus PPX(CT2103
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
Radiation + Temozolomide
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
21
|
|
Overall Study
COMPLETED
|
39
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Radiation Plus PPX(CT2103
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
Radiation + Temozolomide
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
Baseline characteristics by cohort
| Measure |
Radiation Plus PPX(CT2103
n=42 Participants
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
Radiation + Temozolomide
n=21 Participants
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
Total
n=63 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
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
21 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.MRI response evaluated by RANO criteria * Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. * Partial Response (PR): Decrease of \> 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan. * Progression (P): A \> 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT.
Outcome measures
| Measure |
Radiation Plus PPX(CT2103
n=42 Participants
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
Radiation + Temozolomide
n=21 Participants
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
|---|---|---|
|
Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation
|
31 participants
|
15 participants
|
Adverse Events
Radiation Plus PPX and Maintenance
Serious events: 13 serious events
Other events: 40 other events
Deaths: 0 deaths
Radiation + Temozolomide and Maintenance
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation Plus PPX and Maintenance
n=41 participants at risk
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
Radiation + Temozolomide and Maintenance
n=18 participants at risk
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
|---|---|---|
|
Investigations
Anaphylactic Shock
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Aspiration
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Ataxia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Bowel Obstruction
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Cardiac Event
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Constipation
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dysphagia/Swallowing Difficulty
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dysphasia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dyspnea/Shortness of Breath/COPD
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Edema Cerebral/Brain Edema/Cerebral [Localized] Edema
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Headache
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hemiparesis [Increasing] (LF Side)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hyperglycemia
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypocalcemia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypokalemia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypotension
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Infection
|
7.3%
3/41 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Loss of Balance
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased
|
2.4%
1/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Mental Status Changes
|
14.6%
6/41 • Number of events 8 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Nausea/Increased Nausea/Nausea [Increasing]
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Otitis (External)/ media/inflammation middle ear
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Pain chest
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Pulmonary Embolism
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Seizure/Seizures
|
4.9%
2/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Stroke
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Syncope
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Thromboembolic Event
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Vertigo
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Vomitting
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
PNEUMOPERITONEUM
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
WBC
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
SIADH
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
PLT
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
ANC
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
HCT
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
RBC
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
CSF elevated
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Fever
|
2.4%
1/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Creatinine
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Cough
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Anemia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
intratumoral hemorrhage
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
craniotomy
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
pancytopenia
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
pulseless electrical activity
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Abdominal pain
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Gallstones
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
Other adverse events
| Measure |
Radiation Plus PPX and Maintenance
n=41 participants at risk
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ intravenous PPX every week x 6 weeks for a total of 6 treatments
PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
Radiation + Temozolomide and Maintenance
n=18 participants at risk
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
|---|---|---|
|
Investigations
abnormal blood prolactin
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
abrasions/lacerations: face, leg, finger
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Acute gastroenteritis
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Acne On Face and B/L Inguinal Region
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Agitation
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Akathisia
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
ALC Low/ALC Decreased
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
55.6%
10/18 • Number of events 10 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Alk Phos Elevated
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Alopecia
|
53.7%
22/41 • Number of events 22 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
16.7%
3/18 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Allergic reaction
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
LFTS (ALT/AST)
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
22.2%
4/18 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Ambulatory Dysfunction
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Anemia
|
31.7%
13/41 • Number of events 13 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
27.8%
5/18 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Anorexia/Decreased Appetite/Loss of Appetite
|
26.8%
11/41 • Number of events 11 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
22.2%
4/18 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Anxiety/Anxiety [Increasing]
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
apathy
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Aphasia
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Aphasia (Motor)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Appetite (Increased)
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Bells palsy
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
BILATERAL CAROTID BRUIT
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Blurred Vision/Blurry Vision/homonymous hemianopsia(left)/cataracts/periorbital pressure
|
39.0%
16/41 • Number of events 16 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Bloody mucous
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Bowel Incontinence
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Bruising
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
BUN lab
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
CD4 Count Decreased
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
27.8%
5/18 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
congestion/chest/ear
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Chills
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Chronic Obstructive Pulmonary Disease
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Cholesterol
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Constipation
|
22.0%
9/41 • Number of events 9 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
33.3%
6/18 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
cough
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
cramping
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
creatinine
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
CSF elevated protein and collection
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Cushingoid face
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
DARK LESION WITH IRREGULAR BORDERS - RIGHT MEDIAL ANKLE (BENIGN)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
decreased arm swing
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dehydration
|
12.2%
5/41 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Depression
|
12.2%
5/41 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dermatitis
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Diarrhea
|
12.2%
5/41 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dizziness
|
24.4%
10/41 • Number of events 10 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
dry mouth
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dry skin
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dysphagia/Swallowing Difficulty
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Dyspnea/Shortness of Breath
|
17.1%
7/41 • Number of events 7 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
dysgeuisa
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
27.8%
5/18 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
dyspepsia
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Edema Cerebral/Brain Edema/Cerebral [Localized] Edema
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Edema face/neck/hands
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
16.7%
3/18 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Eosinophil count increased
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
erythema
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Fatigue/Increased
|
70.7%
29/41 • Number of events 29 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
88.9%
16/18 • Number of events 19 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Facial Asymmetry
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Fever
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Flushing
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
flu like symptoms
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Forehead trauma
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
fracture
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Gait Unsteadiness/Unsteady Gait/proprioception/ cirumduction, motor deficit
|
22.0%
9/41 • Number of events 9 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
GERD
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Gum soarness
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hand Cramping
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hand tremor
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Headache/Headache (Bifrontal)/Headache [Intermittent]/pressure
|
41.5%
17/41 • Number of events 17 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
50.0%
9/18 • Number of events 9 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hearing loss
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hernia
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hemorrhage (Intratumoral)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hoarseness (Hoarse Voice)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypoalbuminemia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypocalcemia
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hyperglycemia
|
34.1%
14/41 • Number of events 14 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
22.2%
4/18 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypoglycemia
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
hyperlipidemia
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypertension
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypotension
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypertriglyceridemia
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypokalemia
|
24.4%
10/41 • Number of events 10 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hyperkalemia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypernatremia
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypomagnesemia
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypersensitivity to noise
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hyponatremia
|
22.0%
9/41 • Number of events 9 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Hypothyroidism
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
increased sputum
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
incisional tenderness
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Infection
|
36.6%
15/41 • Number of events 17 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
27.8%
5/18 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Insomnia
|
24.4%
10/41 • Number of events 10 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
27.8%
5/18 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Infusion Related Reaction
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
itchiness
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
intratumoral hemorrhage
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
jaw stiffness/tenderness
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
joint stiffness
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Leukopenia
|
24.4%
10/41 • Number of events 10 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Lipase increase
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Lower Extremity Edema (Bilateral)/ foot swelling
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased
|
26.8%
11/41 • Number of events 11 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
33.3%
6/18 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Memory Loss (Worsening Short Term)/memory impairment
|
17.1%
7/41 • Number of events 7 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Mental Status Changes
|
26.8%
11/41 • Number of events 11 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
mucous production increased
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
myopathy
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
narcolepsy
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Nausea/Increased Nausea/Nausea [Increasing]
|
51.2%
21/41 • Number of events 21 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
61.1%
11/18 • Number of events 11 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Neutropenia
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
16.7%
3/18 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Otitis (External)/ media/inflammation middle ear/tinnitus
|
12.2%
5/41 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Ear pain/pressure
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Pain
|
29.3%
12/41 • Number of events 17 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
27.8%
5/18 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Paresthesia (Hand)/LE/oral/neuropathy
|
19.5%
8/41 • Number of events 8 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
PLTs
|
41.5%
17/41 • Number of events 17 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
33.3%
6/18 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
pain post herpatic neuralgia
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Rash/skin irritation,seborrheic keratosis, desquamation of skin, maculopapular rash
|
14.6%
6/41 • Number of events 6 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
22.2%
4/18 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
pruritis
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Psoriatic nails
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Scrotal discomfort
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Seizure/Seizures
|
17.1%
7/41 • Number of events 7 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
sensory loss
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
sinusitis/post nasal
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Skin lesions/ulceration
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Somnolence
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Swelling of Scalp [at Incision Site and Right Eyelid]
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
spasm extremity
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Speech issues/vocal change
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Stroke
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Syncope
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
systolic murmur
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Tachycardia (Sinus)
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Tachypnea
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Tooth ache
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Tremor
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Thromboembolic Event
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
ulcer
|
0.00%
0/41 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Urinary Incontinence
|
4.9%
2/41 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Urinary frequency
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
11.1%
2/18 • Number of events 2 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Wasting (General)
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Watering eyes
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm)
|
36.6%
15/41 • Number of events 15 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Weight Gain
|
7.3%
3/41 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Weight Loss
|
12.2%
5/41 • Number of events 5 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
16.7%
3/18 • Number of events 3 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Wheezing
|
2.4%
1/41 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
0.00%
0/18 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
|
Investigations
Vomiting
|
9.8%
4/41 • Number of events 4 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
5.6%
1/18 • Number of events 1 • Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
|
Additional Information
Howard Safran, MD
Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place