Trial Outcomes & Findings for Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors (NCT NCT00441142)
NCT ID: NCT00441142
Last Updated: 2019-03-05
Results Overview
The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
119 participants
Primary outcome timeframe
2 years
Results posted on
2019-03-05
Participant Flow
Although 119 pts were registered \& enrolled to trial, only 111 began study tx (8 enrolled pts did not receive tx on study). 7 pts randomized to Ph II Arm A removed their consent before starting study tx, and 1 Ph II Arm B pt was removed from study before starting tx, as pt clinically declined immediately following registration/randomization.
Participant milestones
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
29
|
69
|
|
Overall Study
COMPLETED
|
0
|
0
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
22
|
68
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
22
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
17
|
32
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
10
|
|
Overall Study
Patient still receiving active study tx
|
1
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
Baseline characteristics by cohort
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
n=6 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
n=7 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
n=29 Participants
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
n=69 Participants
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Total
n=111 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Baseline (Day 1) Karnofsky Performance Score (KPS)
100
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Baseline (Day 1) Karnofsky Performance Score (KPS)
90
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Baseline (Day 1) Karnofsky Performance Score (KPS)
80
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Baseline (Day 1) Karnofsky Performance Score (KPS)
70
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Baseline (Day 1) Karnofsky Performance Score (KPS)
60
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This measure was only assessed in Participants enrolled into the Phase I part of the study who had available data for analysis.
The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.
Outcome measures
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
n=6 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
n=6 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
Number of Participants That Experienced a Dose-limiting Toxicity (DLT)
|
3 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: This measure was only assessed in Participants in Phase II part of the study, who had available data for analysis
The primary outcome of Phase II of this trial was to determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival.
Outcome measures
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
n=29 Participants
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
n=69 Participants
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
Median Overall Survival (OS) of Phase II Patients
|
—
|
—
|
15.9 months
Interval 11.0 to 22.5
|
16.6 months
Interval 14.9 to 20.1
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: This is an outcome for Phase II participants only; 0 Phase I participants were included in the analysis.
A secondary outcome of Phase II of this trial is the median progression-free survival (PFS), as calculated by the # of months patients remain progression-free
Outcome measures
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
n=29 Participants
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
n=69 Participants
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free
|
—
|
—
|
6.2 months
Interval 3.9 to 10.4
|
7.7 months
Interval 5.5 to 10.1
|
SECONDARY outcome
Timeframe: Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 6 years.The percentage of adverse events (based on CTCAEv3) reported on study (via case report forms and Reportable AE submissions) that are both high-grade (grade 3, 4, or 5) and considered at least possibly related to study treatment.
Outcome measures
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
n=29 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
n=69 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
PHASE II: Percentage of Grade 3-5 Treatment-Related Adverse Events
|
4.16 percentage of events
Interval 2.56 to 6.35
|
8.37 percentage of events
Interval 6.85 to 10.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 7 years.The percentage of adverse events (based on CTCAEv3) reported on study (via case report forms and Reportable AE submissions) that are both high-grade (grade 3, 4, or 5) and considered at least possibly related to study treatment.
Outcome measures
| Measure |
Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day
n=6 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day
n=7 Participants
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II: Arm A (Control Group: RT + TMZ)
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
|---|---|---|---|---|
|
PHASE I: Percentage of Grade 3-5 Treatment-Related Adverse Events
|
9.48 percentage of events
Interval 5.15 to 15.68
|
4.43 percentage of events
Interval 1.8 to 8.92
|
—
|
—
|
Adverse Events
Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib
Serious events: 52 serious events
Other events: 81 other events
Deaths: 0 deaths
Phase II-Arm A Pts (Control Group): RT + TMZ
Serious events: 15 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib
n=82 participants at risk
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II-Arm A Pts (Control Group): RT + TMZ
n=29 participants at risk；n=30 participants at risk
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
|---|---|---|
|
Blood and lymphatic system disorders
hemoglobin
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
lymphopenia
|
9.8%
8/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
neutrophils
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.0%
3/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
platelets
|
4.9%
4/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.3%
4/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
leukocytes
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
blood/bone marrow: other: hemolytic anemia
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
fatigue
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
fever without neutropenia
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Cardiac disorders
supraventricular and nodal arrhythmia: atrial fibrillation
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Cardiac disorders
hypertension
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Cardiac disorders
hypotension
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
death - disease progression
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
death NOS
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
rash: acne/acneiform
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
wound - non-infectious
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Endocrine disorders
adrenal insufficiency
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
anorexia
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
ascites (non-malignant)
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
dehydration
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
diarrhea w/o prior colostomy
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
duodenum, hemorrhage
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
fistula, colon/cecum/appendix
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
nausea
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
perforation, colon
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
stomach, hemorrhage
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
vomiting
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
CNS, hemorrhage
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage, pulmonary/upper respiratory: nose
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Vascular disorders
hematoma
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Hepatobiliary disorders
cholecystitis
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Hepatobiliary disorders
liver dysfunction/failure (clinical)
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, appendix
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, lung
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, nose
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, skin
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, urinary tract
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.7%
2/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, wound
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection w/ gr3-4 neut, wound
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, anal/perianl
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection: other: eye infection
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection: other: infection of the leg
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
edema: head and neck (cerebral edema)
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
bilirubin
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
metabolic/laboratory: other: immunosupression
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
nonneuropathic generalized weakness
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
nonneuropathic left-side muscle weak
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal/soft tissue: other: steroid myopathy
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
extremity-lower (gait/walking)
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal/soft tissue: other: bulging discs
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
confusion
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.7%
2/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
dizziness
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
mental status
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
neuropathy-motor
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
neuropathy-sensory
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
neurology: other: vasogenic cerebral edema
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
seizure
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.7%
2/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
speech impairment (e.g., dysphasia or aphasia)
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
syncope (fainting)
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
cognitive disturbance
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Eye disorders
vision-blurred
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
pain - chest/thorax NOS
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
pain - head/headache
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
pain - abdomen NOS
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
pain - muscle
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
pain - throat/pharynx/larynx
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
obstruction, airway-bronchus
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion (non-malignant)
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis/pulmonary infiltrates
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Renal and urinary disorders
obstruction-ureteral
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Renal and urinary disorders
renal failure
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Renal and urinary disorders
urinary retention
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Renal and urinary disorders
incontinence, urinary
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.3%
1/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Vascular disorders
thrombosis/thrombus/embolism
|
22.0%
18/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
16.7%
5/30 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
Other adverse events
| Measure |
Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib
n=82 participants at risk
The "Induction" Phase:
ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses.
|
Phase II-Arm A Pts (Control Group): RT + TMZ
n=29 participants at risk；n=30 participants at risk
The "Induction" Phase:
Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.
Followed by the "Maintenance" Phase:
12 cycles of adjuvant temozolomide \[at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given\].
|
|---|---|---|
|
Blood and lymphatic system disorders
hemoglobin
|
46.3%
38/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
65.5%
19/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
leukocytes
|
41.5%
34/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
41.4%
12/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
lymphopenia
|
52.4%
43/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
55.2%
16/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
neutrophils
|
25.6%
21/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
31.0%
9/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
platelets
|
58.5%
48/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
44.8%
13/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
blood/bone marrow: other: decreased hematocrit
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
blood/bone marrow: other: decreased red blood cells
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Blood and lymphatic system disorders
blood/bone marrow: other: increase eosinophils
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Investigations
PTT
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
fatigue
|
75.6%
62/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
75.9%
22/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Psychiatric disorders
insomnia
|
24.4%
20/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Investigations
weight loss
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
22.0%
18/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
20.7%
6/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
chemoradiation dermatitis
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
pruritus/itching
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
28.0%
23/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
rash: acne/acneiform
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
4.9%
4/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Skin and subcutaneous tissue disorders
radiation dermatitis
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Endocrine disorders
cushingnoid appearance
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
17.2%
5/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Endocrine disorders
adrenal insufficiency
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
anorexia
|
19.5%
16/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
31.0%
9/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
constipation
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
31.0%
9/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
diarrhea w/o prior colostomy
|
30.5%
25/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
dyspepsia
|
11.0%
9/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
nausea
|
40.2%
33/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
37.9%
11/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
taste disturbance
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
vomiting
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
dehydration
|
2.4%
2/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, oral cavity
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, conjunctiva
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, upper airway
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Infections and infestations
infection gr0-2 neut, urinary tract
|
4.9%
4/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage, pulmonary/upper respiratory: nose
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
edema, head and neck
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
General disorders
edema, limb
|
12.2%
10/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
17.2%
5/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
alkaline phosphatase
|
13.4%
11/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
58.5%
48/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
51.7%
15/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
45.1%
37/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
34.5%
10/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
bicarbonate
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
27.6%
8/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
bilirubin
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
creatinine
|
22.0%
18/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypercalcemia
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
61.0%
50/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
65.5%
19/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
22.0%
18/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
17.2%
5/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypernatremia
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
23.2%
19/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
23.2%
19/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypokalemia
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
24.1%
7/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hyponatremia
|
30.5%
25/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
17.2%
5/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
26.8%
22/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
24.1%
7/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
proteinuria
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
17.2%
5/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
hyperuricemia
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
metabolic/laboratory: other: elevated BUN
|
3.7%
3/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Metabolism and nutrition disorders
metabolic/laboratory: other: hyperphosphatemia
|
1.2%
1/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
extremity-lower (gait/walking)
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
nonneuropathic generalized weakness
|
11.0%
9/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
nonneuropathic left-side muscle weak
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
nonneuropathic lower extr muscle weak
|
9.8%
8/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
anxiety
|
17.1%
14/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
ataxia
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
cognitive disturbance
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
20.7%
6/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
confusion
|
17.1%
14/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
depression
|
23.2%
19/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
dizziness
|
18.3%
15/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
20.7%
6/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
memory impairment
|
24.4%
20/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
24.1%
7/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
neuropathy CN II vision
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
0.00%
0/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
neuropathy-motor
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
neuropathy-sensory
|
13.4%
11/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
seizure
|
13.4%
11/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
17.2%
5/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
speech impairment
|
9.8%
8/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
20.7%
6/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
tremor
|
14.6%
12/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
personality
|
0.00%
0/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Eye disorders
vision - blurred
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Gastrointestinal disorders
pain, abdomen, NOS
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
pain, back
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
pain, extremity-limb
|
7.3%
6/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Nervous system disorders
pain, head/headache
|
35.4%
29/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
55.2%
16/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Musculoskeletal and connective tissue disorders
pain, joint
|
6.1%
5/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
6.9%
2/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
20.7%
17/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
3.4%
1/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.5%
7/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
24.1%
7/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Renal and urinary disorders
urinary frequency/urgency
|
13.4%
11/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Renal and urinary disorders
incontinence urinary
|
4.9%
4/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
10.3%
3/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
|
Vascular disorders
thrombosis/thrombus/embolism
|
22.0%
18/82 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
13.8%
4/29 • AEs & SAEs are collected from consent throughout tx period, including a follow-up period (30 days after last dose or until resolution). All study-related AEs are followed until resolution, unless deemed by the Investigator unlikely to resolve.
Although 29 pts received study tx in the Phase II - Arm A group, the # of pts at risk for SAEs in the "Phase II-Arm A Pts (Control Group): RT + TMZ" group is reported as 30 to include 1 additional Arm A pt who did not ultimately start study tx who experienced a Reportable AE (gr3 confusion w/ urinary incontinence) on the date pt was registered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60