Trial Outcomes & Findings for Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas (NCT NCT01514201)
NCT ID: NCT01514201
Last Updated: 2019-08-13
Results Overview
The traditional 3+3 dose finding algorithm was used to estimate the maximum-tolerated dose of veliparib given concurrently with radiation therapy. The dose-limiting toxicity observation period was the first 10 weeks of therapy. Dose-limiting toxicities included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with a few exceptions (see section 5.2.1.2 of the protocol document), any grade 2 non-hematologic toxicity that persisted for \>7 days and considered medically significant that required treatment interruption; grade 3 or higher thrombocytopenia or grade 4 neutropenia; and any Veliparib related adverse event that led to a dose reduction or the permanent cessation of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
10 weeks
Results posted on
2019-08-13
Participant Flow
Patients up to 21 years of age with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient was enrolled on 2/1/2012 and the last patient was enrolled on 01/20/2016.
Of the 66 patients enrolled, 1 phase II patient was deemed ineligible due to an elevated alanine aminotransferase (ALT). Of note, the 6 phase I patients who were treated at the established maximum tolerated dose (MTD) during the phase I portion of the trial were also counted as phase II patients in analyses of phase II objectives.
Participant milestones
| Measure |
Phase I, Dose Level 1 (50 mg)
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 2 (65 mg)
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 3 (85 mg)
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
PHASE I: Veliparib + Radiation Therapy
STARTED
|
6
|
6
|
6
|
0
|
|
PHASE I: Veliparib + Radiation Therapy
COMPLETED
|
5
|
6
|
6
|
0
|
|
PHASE I: Veliparib + Radiation Therapy
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
PHASE I: Maintenance With Veliparib/TMZ
STARTED
|
5
|
6
|
6
|
0
|
|
PHASE I: Maintenance With Veliparib/TMZ
COMPLETED
|
0
|
0
|
0
|
0
|
|
PHASE I: Maintenance With Veliparib/TMZ
NOT COMPLETED
|
5
|
6
|
6
|
0
|
|
PHASE II: Veliparib + Radiation Therapy
STARTED
|
0
|
0
|
0
|
47
|
|
PHASE II: Veliparib + Radiation Therapy
COMPLETED
|
0
|
0
|
0
|
35
|
|
PHASE II: Veliparib + Radiation Therapy
NOT COMPLETED
|
0
|
0
|
0
|
12
|
|
PHASE II: Maintenance With Veliparib/TMZ
STARTED
|
0
|
0
|
0
|
35
|
|
PHASE II: Maintenance With Veliparib/TMZ
COMPLETED
|
0
|
0
|
0
|
2
|
|
PHASE II: Maintenance With Veliparib/TMZ
NOT COMPLETED
|
0
|
0
|
0
|
33
|
Reasons for withdrawal
| Measure |
Phase I, Dose Level 1 (50 mg)
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 2 (65 mg)
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 3 (85 mg)
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
PHASE I: Veliparib + Radiation Therapy
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
PHASE I: Maintenance With Veliparib/TMZ
Adverse Event
|
0
|
1
|
1
|
0
|
|
PHASE I: Maintenance With Veliparib/TMZ
Lack of Efficacy
|
4
|
4
|
5
|
0
|
|
PHASE I: Maintenance With Veliparib/TMZ
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
PHASE II: Veliparib + Radiation Therapy
Ineligible
|
0
|
0
|
0
|
1
|
|
PHASE II: Veliparib + Radiation Therapy
Adverse Event
|
0
|
0
|
0
|
2
|
|
PHASE II: Veliparib + Radiation Therapy
Death
|
0
|
0
|
0
|
1
|
|
PHASE II: Veliparib + Radiation Therapy
Lack of Efficacy
|
0
|
0
|
0
|
2
|
|
PHASE II: Veliparib + Radiation Therapy
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
|
PHASE II: Maintenance With Veliparib/TMZ
Adverse Event
|
0
|
0
|
0
|
4
|
|
PHASE II: Maintenance With Veliparib/TMZ
Withdrawal by Subject
|
0
|
0
|
0
|
7
|
|
PHASE II: Maintenance With Veliparib/TMZ
Lack of Efficacy
|
0
|
0
|
0
|
22
|
Baseline Characteristics
Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas
Baseline characteristics by cohort
| Measure |
Phase I, Dose Level 1 (50 mg)
n=6 Participants
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 2 (65 mg)
n=6 Participants
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 3 (85 mg)
n=6 Participants
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase II (MTD)
n=47 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 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
>=65 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, Continuous
|
6.3 years
n=5 Participants
|
10.2 years
n=7 Participants
|
9.2 years
n=5 Participants
|
6.5 years
n=4 Participants
|
6.6 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
40 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial.
The traditional 3+3 dose finding algorithm was used to estimate the maximum-tolerated dose of veliparib given concurrently with radiation therapy. The dose-limiting toxicity observation period was the first 10 weeks of therapy. Dose-limiting toxicities included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with a few exceptions (see section 5.2.1.2 of the protocol document), any grade 2 non-hematologic toxicity that persisted for \>7 days and considered medically significant that required treatment interruption; grade 3 or higher thrombocytopenia or grade 4 neutropenia; and any Veliparib related adverse event that led to a dose reduction or the permanent cessation of therapy.
Outcome measures
| Measure |
Phase I Patients
n=18 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Maximum-tolerated Dose of Veliparib Defined as Highest Dose Level With Fewer Than 2 Dose Limiting Toxicities in 6 Patients as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)
|
65 mg/m2/dose BID
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days per treatment cyclePopulation: Patients were combined across dose levels since they received the same maintenance therapy. Though this objective was intended for all patients, only the first 12 enrolled were included as the dose-escalation stopped early. 1 of the first 12 patients did not start maintenance due to early progression, so 11 patients started dose level 1.
Unacceptable toxicities during maintenance included events at least possibly attributable to Veliparib and temozolomide (TMZ) such as any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., grade 3 nausea/vomiting \<5 days, grade 3 fever or infection \<5 days), grade 3+ thrombocytopenia, grade 4 neutropenia, delay \>14 days in starting subsequent cycle due to neutrophil \<1,000/mm3 or platelet \<100,000/mm3. Maintenance therapy was initiated with 25 mg/m2 Veliparib and 135 mg/m2 of TMZ, with the possibility to escalate TMZ to 175 mg/m2 and 200 mg/m2 in courses 2 and 3, respectively, if no unacceptable toxicities occurred following one course of treatment at each of the dose levels to be tested. Intra-patient dose escalation to a given dose (135, 175, or 200 mg/m2) was halted based on rules employed in 3+3 designs. This dose escalation was intended for all patients but was halted early, during the phase I portion, as it was not well tolerated.
Outcome measures
| Measure |
Phase I Patients
n=11 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=5 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=3 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Percentage of Participants Observed to Have Unacceptable Toxicity During the Intra-patient Dose Escalation of Temozolomide During Maintenance Therapy (Feasibility Analysis Population)
|
9 % of participants
|
40 % of participants
|
67 % of participants
|
—
|
PRIMARY outcome
Timeframe: Time from initiation of therapy to the date of death from any cause or to the date patient was known to be alive for surviving patients, assessed to up to 3 yearsPopulation: 53 patients were evaluable for outcome analyses (47 phase II patients + 6 phase I patients treated at the MTD). 50 patients were evaluable; 1 patient withdrew prior to beginning protocol therapy and 2 patients did not receive adequate study drug to be evaluable for efficacy. To be evaluable patients had to receive at least one dose of Veliparib.
Overall survival was defined as the interval from date on treatment to date of death from any cause or to date of last follow-up. Patients who had not failed (died) at the time of analyses were censored at their last date of contact. The method of Kaplan and Meier was used to estimate overall survival. The 3-year estimate with a 95% confidence interval is reported.
Outcome measures
| Measure |
Phase I Patients
n=50 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Overall Survival
|
5.3 Percent probability
Interval 0.0 to 12.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 10 weeksDLTs were defined as any of the following adverse events that were at least possibly attributable to Veliparib observed during the dose finding phase (the first 10 weeks of therapy). Hematologic dose limiting toxicities included grade 3 and higher thrombocytopenia or grade 4 neutropenia. Non-hematologic dose limiting toxicities included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of \<5 days; fever or infection of \<5 days; hypophosphatemia, hypokalemia, hypocalcemia or hypomagnesemia responsive to oral supplementation; elevation of transaminases that return to levels meeting eligibility criteria within 7 days), or any grade non-hematologic toxicity that persisted for \>7 days and considered medically significant or sufficiently intolerable by patients that required treatment interruption.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Number of Phase I Patients Who Experienced Dose Limiting Toxicities (DLTs)
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Time from initiation of treatment to the earliest date of failure (disease progression, death from any cause, or second malignancy), assessed up to 3 yearsPopulation: 53 patients were evaluable for outcome analyses (47 phase II patients + 6 phase I patients treated at the MTD). 50 patients were evaluable; 1 patient withdrew prior to beginning protocol therapy and 2 patients did not receive adequate study drug to be evaluable for efficacy. To be evaluable patients had to receive at least one dose of Veliparib.
PFS was defined as the interval from date of treatment initiation to date of first event (disease progression or relapse, second malignancy or death from any cause). Patients who had not failed at the time of analyses were censored at their last date of contact. The method of Kaplan and Meier was used to estimate PFS. A 3-year estimate with a 95% confidence interval is reported.
Outcome measures
| Measure |
Phase I Patients
n=50 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
2.9 Percent probability
Interval 0.0 to 6.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsFor participants that showed possible tumor progression (pseudo progression) on magnetic resonance imaging (MRI) during the first 6 months of therapy, treating physicians had the option of allowing patients to remain on therapy and repeating the disease assessment in 4-6 weeks. If the repeat MRI at 4-6 weeks showed disease progression, the patient was noted to have true disease progression (and the progression date corresponded to that of the first MRI). If the repeat MRI at 4-6 weeks did not show disease progression, then the patient was noted to have pseudo progression. The percentage of patients observed to have experienced pseudo progression was provided with a 95% confidence interval.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=47 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Percentage of Patients With Pseudo Progression
|
33.3 Percentage of participants
Interval 6.3 to 72.9
|
16.7 Percentage of participants
Interval 0.9 to 59.8
|
0 Percentage of participants
Interval 0.0 to 40.2
|
12.8 Percentage of participants
Interval 5.7 to 24.5
|
SECONDARY outcome
Timeframe: Up to day 4Population: Pharmacokinetic studies were optional for the phase II portion of the study. Pharmacokinetic data were not available for all patients as indicated in the outcome measure data table below.
During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis. Cmax measures the highest concentration of drug.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=47 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Maximum Concentration of Veliparib (Cmax) on Days 1 and 4 (Measured in ng/mL) [Pharmacokinetic Parameter]
Day 1, Cmax (ng/mL)
|
519 ng/mL
Standard Deviation 241
|
843 ng/mL
Standard Deviation 364
|
1074 ng/mL
Standard Deviation 372
|
844 ng/mL
Standard Deviation 279
|
|
Maximum Concentration of Veliparib (Cmax) on Days 1 and 4 (Measured in ng/mL) [Pharmacokinetic Parameter]
Day 4, Cmax (ng/mL)
|
409 ng/mL
Standard Deviation 84
|
788 ng/mL
Standard Deviation 435
|
954 ng/mL
Standard Deviation 348
|
717 ng/mL
Standard Deviation 232
|
SECONDARY outcome
Timeframe: Up to day 4Population: Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 6/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 25/47 phase II patients had this data available.
During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=25 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Mean Apparent Clearance (CL/F) for Veliparib [Pharmacokinetic Parameter]
|
16.1 L/m^2/h
Standard Deviation 8.1
|
13.2 L/m^2/h
Standard Deviation 4.3
|
15.8 L/m^2/h
Standard Deviation 8.3
|
11.7 L/m^2/h
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic studies were optional for the phase II portion of the study. Pharmacokinetic data were not available for all patients. 6/6 phase I dose level 1, 6/6 phase I dose level 2, 4/6 phase I dose level 3, and 25/47 phase II patients had day 4 Cmax data available.
During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis. Cmax measures the highest concentration of drug.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=25 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Maximum Concentration of Veliparib (Cmax) on Day 1 (Measured in μM) [Pharmacokinetic Parameter]
|
2.12 μM
Standard Deviation 0.98
|
3.45 μM
Standard Deviation 1.49
|
4.40 μM
Standard Deviation 1.52
|
3.45 μM
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Up to day 4Population: Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 6/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 25/47 phase II patients had this data available.
During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=25 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) for Veliparib [Pharmacokinetic Parameter]
|
75.4 L/m^2
Standard Deviation 29.2
|
56.1 L/m^2
Standard Deviation 25.4
|
63.9 L/m^2
Standard Deviation 10.6
|
73.1 L/m^2
Standard Deviation 109.7
|
SECONDARY outcome
Timeframe: Up to day 4Population: Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 6/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 25/47 phase II patients had this data available.
During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=25 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2) for Veliparib [Pharmacokinetic Parameter]
|
5.18 Hour
Standard Deviation 6.34
|
2.62 Hour
Standard Deviation 0.76
|
4.45 Hour
Standard Deviation 4.80
|
2.18 Hour
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Up to day 4Population: Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 5/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 20/47 phase II patients had this data available.
During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=5 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=20 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Trough for Veliparib [Pharmacokinetic Parameter]
|
58 ng/mL
Standard Deviation 19
|
140 ng/mL
Standard Deviation 173
|
163 ng/mL
Standard Deviation 97
|
84 ng/mL
Standard Deviation 42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to 11 weeksPopulation: Only 27 patients had pre- and post-Veliparib samples available in order to assess treatment-related changes. Two of the patients had inconsistent changes in post-Veliparib PARP levels and therefore were excluded from the analysis, leaving 25 patients for this objective.
Blood samples were collected from patients and assessed pre- and post-Veliparib to assess treatment-induced changes. A significant change in PBMC PARP level was arbitrarily defined as a \>50% increase or decrease from the pre-treatment level, documented at week 6 and/or week 11 after starting protocol therapy.
Outcome measures
| Measure |
Phase I Patients
n=3 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=4 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=14 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Percentage of Participants With Significant Changes in Poly(ADP-ribose) Polymerase (PARP) Levels Post-Veliparib, as Measured in Peripheral Blood Monocytes (PBMCs)
|
100 percentage of participants
Interval 37.0 to 100.0
|
100 percentage of participants
Interval 47.0 to 100.0
|
75 percentage of participants
Interval 25.0 to 99.0
|
36 percentage of participants
Interval 15.0 to 63.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 3 yearsPopulation: These data were not available as the lab did not perform these analyses. There are no plans to perform these analyses.
Levels of non-homologous end-joining (NHEJ) activity were to be calculated. Cox models to explore associations between the levels of NHEJ and outcome (progression-free survival and overall survival) were planned, in addition to looking at associations between Poly(ADP-ribose) polymerase (PARP) activity and NHEJ levels.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 3 yearsPopulation: These data were not available as the lab did not perform these analyses. There are no plans to perform these analyses.
Levels of gamma-H2A histone family, member X (H2AX) were to be calculated. Cox models to explore associations between the levels of gamma-H2AX and outcome (progression-free survival and overall survival) were planned, in addition to looking at associations between Poly(ADP-ribose) polymerase (PARP) activity and gamma-H2AX levels.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 3 yearsPopulation: Not all patients had urine samples at each time point.
Urine samples were analyzed for a panel of biomarkers. Netrin-1 levels were determined by ELISA. Levels of matrix metalloproteinase 3 (MMP3) and basic fibroblast growth factor (bFGF) were analyzed using custom Luminex® screening assays. Tissue inhibitor of metalloproteinase 1 (TIMP1) levels were analyzed using a Luminex® performance assay. Protein concentrations are given in picograms per microgram (pg/μg), and were determined by dividing the concentration of the target protein in the sample (pg/mL) by the concentration of total protein in the sample (μg/mL) as a normalization measure.
Outcome measures
| Measure |
Phase I Patients
n=6 Participants
The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial. The starting dose level was 50 mg/m2/dose twice a day (BID) and other dose levels to be studied were 65 and 85 mg/m2/dose BID. If the 85 mg/m2 dose level was tolerated, there was a plan to study a higher dose level (110 mg/m2/dose BID) but only if supported by clinical data.
|
Dose Level 2 (175 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 2 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 175 mg/m2/day)
|
Dose Level 3 (200 mg/m2)
n=6 Participants
Participants in the feasibility analysis population that started dose level 1 of the intra-patient dose escalation during maintenance (Veliparib 25 mg/m2 twice a day (BID) + temozolomide 200 mg/m2/day)
|
Phase II (MTD)
n=47 Participants
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo 3-dimensional conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Levels of Urinary Biomarkers
MMP3 at pre-study
|
2.0 pg/μg
Interval 0.9 to 3.2
|
1.0 pg/μg
Interval 0.4 to 2.1
|
0.0 pg/μg
Interval 0.0 to 2.6
|
1.1 pg/μg
Interval 0.0 to 7.6
|
|
Levels of Urinary Biomarkers
MMP3 at week 10-11
|
1.4 pg/μg
Interval 0.7 to 4.0
|
1.0 pg/μg
Interval 0.0 to 2.9
|
0.8 pg/μg
Interval 0.4 to 3.5
|
2.6 pg/μg
Interval 0.0 to 9.8
|
|
Levels of Urinary Biomarkers
MMP3 at week 18
|
4.3 pg/μg
Interval 4.2 to 4.6
|
1.7 pg/μg
Interval 1.3 to 2.4
|
0.7 pg/μg
Interval 0.5 to 1.0
|
2.3 pg/μg
Interval 0.0 to 15.8
|
|
Levels of Urinary Biomarkers
MMP3 at week 26
|
2.9 pg/μg
Interval 2.8 to 3.0
|
0.4 pg/μg
Interval 0.3 to 0.5
|
1.0 pg/μg
Interval 1.0 to 1.1
|
3.0 pg/μg
Interval 0.2 to 6.4
|
|
Levels of Urinary Biomarkers
Netrin-1 at pre-study
|
0.1 pg/μg
Interval 0.0 to 0.3
|
0.1 pg/μg
Interval 0.1 to 0.2
|
0.1 pg/μg
Interval 0.0 to 0.3
|
0.1 pg/μg
Interval 0.0 to 0.9
|
|
Levels of Urinary Biomarkers
Netrin-1 at week 10-11
|
0.1 pg/μg
Interval 0.1 to 0.3
|
0.1 pg/μg
Interval 0.0 to 0.3
|
0.1 pg/μg
Interval 0.0 to 0.5
|
0.0 pg/μg
Interval 0.0 to 0.3
|
|
Levels of Urinary Biomarkers
Netrin-1 at week 18
|
0.3 pg/μg
Interval 0.2 to 0.3
|
0.1 pg/μg
Interval 0.1 to 0.1
|
0.0 pg/μg
Interval 0.0 to 0.0
|
0.1 pg/μg
Interval 0.0 to 0.6
|
|
Levels of Urinary Biomarkers
Netrin-1 at week 26
|
0.4 pg/μg
Interval 0.4 to 0.4
|
0.2 pg/μg
Interval 0.2 to 0.3
|
0.0 pg/μg
Interval 0.0 to 0.0
|
0.0 pg/μg
Interval 0.0 to 1.0
|
|
Levels of Urinary Biomarkers
TIMP1 at pre-study
|
3.4 pg/μg
Interval 3.1 to 9.0
|
9.9 pg/μg
Interval 1.4 to 18.7
|
10.8 pg/μg
Interval 1.5 to 39.7
|
7.3 pg/μg
Interval 1.9 to 16.8
|
|
Levels of Urinary Biomarkers
TIMP1 at week 10-11
|
6.2 pg/μg
Interval 4.0 to 22.4
|
11.9 pg/μg
Interval 0.0 to 40.5
|
12.3 pg/μg
Interval 7.8 to 143.7
|
7.5 pg/μg
Interval 3.5 to 20.3
|
|
Levels of Urinary Biomarkers
TIMP1 at week 18
|
10.7 pg/μg
Interval 2.9 to 18.1
|
7.7 pg/μg
Interval 5.8 to 9.6
|
14.8 pg/μg
Interval 12.0 to 61.9
|
7.1 pg/μg
Interval 2.4 to 44.7
|
|
Levels of Urinary Biomarkers
TIMP1 at week 26
|
7.3 pg/μg
Interval 7.2 to 7.4
|
5.2 pg/μg
Interval 2.6 to 7.8
|
32.8 pg/μg
Interval 4.9 to 60.7
|
10.7 pg/μg
Interval 2.4 to 30.8
|
|
Levels of Urinary Biomarkers
bFGF at pre-study
|
3.1 pg/μg
Interval 1.3 to 7.8
|
1.9 pg/μg
Interval 1.0 to 3.7
|
1.2 pg/μg
Interval 0.0 to 3.0
|
4.5 pg/μg
Interval 0.0 to 18.5
|
|
Levels of Urinary Biomarkers
bFGF at week 10-11
|
3.6 pg/μg
Interval 3.3 to 9.3
|
2.1 pg/μg
Interval 0.8 to 6.4
|
1.8 pg/μg
Interval 0.8 to 2.7
|
3.5 pg/μg
Interval 0.0 to 9.4
|
|
Levels of Urinary Biomarkers
bFGF at week 18
|
10.3 pg/μg
Interval 7.1 to 10.9
|
3.5 pg/μg
Interval 1.5 to 5.2
|
1.3 pg/μg
Interval 0.6 to 1.4
|
4.4 pg/μg
Interval 0.0 to 40.8
|
|
Levels of Urinary Biomarkers
bFGF at week 26
|
7.7 pg/μg
Interval 7.0 to 8.4
|
0.9 pg/μg
Interval 0.6 to 1.2
|
1.1 pg/μg
Interval 1.1 to 1.1
|
4.5 pg/μg
Interval 0.3 to 66.0
|
Adverse Events
Phase I, Dose Level 1 (50 mg/m2)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase I, Dose Level 2 (65 mg/m2)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase I, Dose Level 3 (85 mg/m2)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase II (MTD)
Serious events: 19 serious events
Other events: 46 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Phase I, Dose Level 1 (50 mg/m2)
n=6 participants at risk
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 2 (65 mg/m2)
n=6 participants at risk
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 3 (85 mg/m2)
n=6 participants at risk
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase II (MTD)
n=47 participants at risk
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Hydrocephalus
|
50.0%
3/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
17.0%
8/47 • Number of events 9 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Intracranial hemorrhage
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
16.7%
1/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Renal calculi
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Fever
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Death NOS
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Pain
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Eye disorders
Papilledema
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Serum amylase increased
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
Other adverse events
| Measure |
Phase I, Dose Level 1 (50 mg/m2)
n=6 participants at risk
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 2 (65 mg/m2)
n=6 participants at risk
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase I, Dose Level 3 (85 mg/m2)
n=6 participants at risk
Dose Escalation: Patients receive veliparib orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide (TMZ) PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early as it was not well tolerated.
|
Phase II (MTD)
n=47 participants at risk
Patients receive veliparib at the maximum tolerated dose (MTD) orally (PO) twice a day (BID) 5 days a week for 6-7 weeks. Patients also undergo concurrent radiation (3D-CRT or IMRT) once a day (QD) 5 days a week for 6-7 weeks.
Maintenance Therapy: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5 and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. All patients start maintenance with 25 mg/m2 BID of veliparib and 135 mg/m2/day of TMZ. Intra-patient escalation of TMZ to 175 mg/m2/day and 200 mg/m2/day in subsequent courses was allowed for patients with minimal toxicities. However this intra-patient dose escalation was halted early (before the phase II study was initiated) as it was not well tolerated.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 11 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 20 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
100.0%
6/6 • Number of events 13 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
57.4%
27/47 • Number of events 59 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Ear and labyrinth disorders
External ear inflammation
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Endocrine disorders
Cushingoid
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
83.3%
5/6 • Number of events 6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
29.8%
14/47 • Number of events 19 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 7 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
83.3%
5/6 • Number of events 7 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 7 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
29.8%
14/47 • Number of events 23 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Stomach pain
|
16.7%
1/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 11 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 12 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
44.7%
21/47 • Number of events 35 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
50.0%
3/6 • Number of events 7 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
31.9%
15/47 • Number of events 26 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Fever
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Hypothermia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
48.9%
23/47 • Number of events 33 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
25.5%
12/47 • Number of events 22 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
GGT increased
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 11 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Lymphocyte count decreased
|
83.3%
5/6 • Number of events 15 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
100.0%
6/6 • Number of events 34 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
100.0%
6/6 • Number of events 27 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
93.6%
44/47 • Number of events 260 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • Number of events 8 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 17 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
83.3%
5/6 • Number of events 24 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
40.4%
19/47 • Number of events 66 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Platelet count decreased
|
83.3%
5/6 • Number of events 14 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
83.3%
5/6 • Number of events 30 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 18 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
48.9%
23/47 • Number of events 72 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Weight gain
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Investigations
White blood cell decreased
|
83.3%
5/6 • Number of events 17 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
83.3%
5/6 • Number of events 36 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
83.3%
5/6 • Number of events 22 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
76.6%
36/47 • Number of events 131 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
21.3%
10/47 • Number of events 14 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 7 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
50.0%
3/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
17.0%
8/47 • Number of events 11 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
38.3%
18/47 • Number of events 33 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
19.1%
9/47 • Number of events 21 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
4/6 • Number of events 8 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
50.0%
3/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
29.8%
14/47 • Number of events 22 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
12.8%
6/47 • Number of events 6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
29.8%
14/47 • Number of events 20 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
6.4%
3/47 • Number of events 6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Abducens nerve disorder
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Ataxia
|
66.7%
4/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
50.0%
3/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 9 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
50.0%
3/6 • Number of events 4 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
66.7%
4/6 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
14.9%
7/47 • Number of events 12 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
IVth nerve disorder
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Oculomotor nerve disorder
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Psychiatric disorders
Personality change
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
8.5%
4/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
33.3%
2/6 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
10.6%
5/47 • Number of events 6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
2.1%
1/47 • Number of events 2 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
4.3%
2/47 • Number of events 5 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/6 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
16.7%
1/6 • Number of events 1 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
0.00%
0/47 • Approximately 1 year after starting treatment
Adverse events (AEs) were graded according to CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to veliparib and b) all grade 3+ AEs on treatment and within 30 days off treatment. All AEs collected are reported. As the intra-patient escalation of TMZ during maintenance was by course (rather than patient) and was halted early (only 5(3) patients escalated to 175(200) mg/m2), AEs were not reported separately by course-specific doses.
|
Additional Information
Catherine Billups
St. Jude Children's Research Hospital
Phone: 901-595-3709
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60