Trial Outcomes & Findings for Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma (NCT NCT02974621)
NCT ID: NCT02974621
Last Updated: 2025-08-03
Results Overview
Progression-Free Survival (PFS) is defined as the time from randomization to progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, whichever occurs first. Participants alive without PD are censored at date of last disease evaluation. PD criteria: (A) 25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response or baseline if no decrease) on stable or increasing doses of steroids and/or one or more of the following: (B) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of steroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events (C) Any new lesions (D) Clear clinical deterioration not attributable to other causes apart from the tumor, per discretion of the treating physician (E) Failure to return for evaluation due to death or deteriorating condition.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
Arm A (Olaparib, Cediranib Maleate)
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
Reasons for withdrawal
| Measure |
Arm A (Olaparib, Cediranib Maleate)
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Overall Study
Didn't receive study treatment
|
1
|
10
|
Baseline Characteristics
Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=35 Participants
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=35 Participants
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
n=5 Participants
|
61.0 years
n=7 Participants
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Karnofsky performance status
Score = 100
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Karnofsky performance status
Score = 90
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Karnofsky performance status
Score = 80
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Karnofsky performance status
Score = 70
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Karnofsky performance status
Score = 60
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Time from initial surgery to study randomization
|
375 days
n=5 Participants
|
309 days
n=7 Participants
|
353 days
n=5 Participants
|
|
Number of Disease Recurrence
1 recurrence
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Number of Disease Recurrence
2 recurrences
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Surgery
Resection
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Surgery
Biopsy
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
IDH mutation
Yes
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
IDH mutation
No
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
IDH mutation
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
MGMT promoter methylation
Methylated
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
MGMT promoter methylation
Unmethylated
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
MGMT promoter methylation
Indeterminate
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
MGMT promoter methylation
Unknown
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: There were 1 participant in Arm A (cediranib plus olaparib) and 10 participants in Arm B (bevacizumab) that did not receive study treatment. These participants were included in the survival analysis as part of the intention-to-treat population.
Progression-Free Survival (PFS) is defined as the time from randomization to progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, whichever occurs first. Participants alive without PD are censored at date of last disease evaluation. PD criteria: (A) 25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response or baseline if no decrease) on stable or increasing doses of steroids and/or one or more of the following: (B) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of steroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events (C) Any new lesions (D) Clear clinical deterioration not attributable to other causes apart from the tumor, per discretion of the treating physician (E) Failure to return for evaluation due to death or deteriorating condition.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=35 Participants
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=35 Participants
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Number of Participants With Progression-Free Survival at 6 Months
|
16 percentage of participants
Interval 5.0 to 32.0
|
28 percentage of participants
Interval 11.0 to 47.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: There were 1 participant in Arm A (cediranib plus olaparib) and 10 participants in Arm B (bevacizumab) that did not receive study treatment. These participants were included in the survival analysis as part of the intention-to-treat population.
Progression free survival is defined as the time from randomization until progressive disease or death from any cause.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=35 Participants
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=35 Participants
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Progression Free Survival
|
118 days
Interval 63.0 to 173.0
|
92 days
Interval 45.0 to 142.0
|
SECONDARY outcome
Timeframe: up to 3 yearsPopulation: There were 1 participant in Arm A (cediranib plus olaparib) and 10 participants in Arm B (bevacizumab) that did not receive study treatment. These participants were included in the survival analysis as part of the intention-to-treat population.
Overall Survival (OS) is defined as the time from randomization to death due to any cause, or censored at date last known alive.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=35 Participants
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=35 Participants
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Overall Survival (OS)
|
316 days
Interval 178.0 to 459.0
|
218 days
Interval 135.0 to 368.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe grade of adverse events be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events 5.0. The incidence of an adverse event at a particular grade is the number of patients who experienced that adverse event/grade.
Outcome measures
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=34 Participants
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=25 Participants
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Incidence of Adverse Events (AE)
Paronychia · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AE)
Paronychia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Dehydration · No grade 3 or above events
|
33 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Paronychia · No grade 3 or above events
|
34 Participants
|
24 Participants
|
|
Incidence of Adverse Events (AE)
Anemia · Grade 3
|
2 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Anemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Anemia · No grade 3 or above events
|
32 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Leukopenia · Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Leukopenia · Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Leukopenia · No grade 3 or above events
|
33 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Neutropenia · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Neutropenia · Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Neutropenia · No grade 3 or above events
|
32 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Lymphopenia · Grade 3
|
2 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Lymphopenia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Lymphopenia · No grade 3 or above events
|
32 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Thrombocytopenia · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AE)
Thrombocytopenia · Grade 4
|
1 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AE)
Thrombocytopenia · No grade 3 or above events
|
33 Participants
|
23 Participants
|
|
Incidence of Adverse Events (AE)
Hypertension · Grade 3
|
3 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Hypertension · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Hypertension · No grade 3 or above events
|
31 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Heart Failure · Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Heart Failure · Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Heart Failure · No grade 3 or above events
|
33 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Transaminitis · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Transaminitis · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Transaminitis · No grade 3 or above events
|
33 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Intracranial hemorrhage · Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events (AE)
Intracranial hemorrhage · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Intracranial hemorrhage · No grade 3 or above events
|
34 Participants
|
24 Participants
|
|
Incidence of Adverse Events (AE)
Muscle weakness of lower limb · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Muscle weakness of lower limb · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Muscle weakness of lower limb · No grade 3 or above events
|
33 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Hypokalemia · Grade 3
|
2 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Hypokalemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Hypokalemia · No grade 3 or above events
|
32 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Thromboembolic event · Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Thromboembolic event · Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Thromboembolic event · No grade 3 or above events
|
33 Participants
|
25 Participants
|
|
Incidence of Adverse Events (AE)
Dehydration · Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Events (AE)
Dehydration · Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsDescriptive statistics will be provided for all continuous biomarkers outcomes. Contingency tables will be provided for categorical data. All comparisons between study arms will be adjusted for multiplicity and in particular false discovery rate (FDR) (Hochberg and Binaymini) will be used for genome data. Binary endpoints will be reported using 95% binomial confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsDescriptive statistics will be provided for all continuous biomarkers outcomes. Contingency tables will be provided for categorical data. All comparisons between study arms will be adjusted for multiplicity and in particular FDR (Hochberg and Binaymini) will be used for genome data. Binary endpoints will be reported using 95% binomial confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsWill be assessed by whole exome sequencing. Descriptive statistics will be provided for all continuous biomarkers outcomes. Contingency tables will be provided for categorical data. All comparisons between study arms will be adjusted for multiplicity and in particular FDR (Hochberg and Binaymini) will be used for genome data. Binary endpoints will be reported using 95% binomial confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsDescriptive statistics will be provided for all continuous biomarkers outcomes. Contingency tables will be provided for categorical data. All comparisons between study arms will be adjusted for multiplicity and in particular FDR (Hochberg and Binaymini) will be used for genome data. Binary endpoints will be reported using 95% binomial confidence intervals.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Olaparib, Cediranib Maleate)
Serious events: 16 serious events
Other events: 33 other events
Deaths: 31 deaths
Arm B (Bevacizumab)
Serious events: 13 serious events
Other events: 24 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=34 participants at risk
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=25 participants at risk
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Cardiac disorders
Heart Failure
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Death, not otherwise specified
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Fever
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Esophagitis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
White blood cell decreased
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Disease Progression
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Seizure
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Somnolence
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Infections & infestations - Other - Upper Respiratory Infection
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Joint infection
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Diabetes Insipidus
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
Other adverse events
| Measure |
Arm A (Olaparib, Cediranib Maleate)
n=34 participants at risk
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cediranib: Given PO
Cediranib Maleate: Given PO
Olaparib: Given PO
|
Arm B (Bevacizumab)
n=25 participants at risk
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
17.6%
6/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Agitation
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Alkaline phosphatase increased
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
ALT increased
|
32.4%
11/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Amnesia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Blood and lymphatic system disorders
Anemia
|
17.6%
6/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.3%
12/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
AST increased
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Ataxia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Blood bilirubin increased
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Decreased Rbc
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Elevated White Blood Count
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Hyperphosphatemia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Lft Abnormailities
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Eye disorders
Blurred vision
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Concentration impairment
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Confusion
|
11.8%
4/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
4/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Creatinine increased
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
55.9%
19/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Eye disorders
Dry eye
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Dysarthria
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
4/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Dysphasia
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Ear and labyrinth disorders
Ear and Labyrinth - Other - Ears Feeled Stuffed Up Like A Head Cold
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Edema face
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Edema limbs
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Edema trunk
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Eye disorders
Eye disorders - Other, specify - Diplopia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Eye disorders
Eye disorders - Other, specify - Left Homonymous Hemianopsia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Eye disorders
Eye disorders - Other, specify - Left Sided Field Cut
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Injury, poisoning and procedural complications
Fall
|
20.6%
7/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
20.0%
5/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Fatigue
|
35.3%
12/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
32.0%
8/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Fever
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Flu like symptoms
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Gait disturbance
|
26.5%
9/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Abdominal Discomfort
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Decreased Dexterity
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Double Vision
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Executive Dysfunction
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Failure To Thrive
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Mood Swings
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Ptosis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Temperature Intolerance
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
General and admin site - Other - Voice Hoarseness
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Belching
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Dysuria
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Gi Virus
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Headache
|
23.5%
8/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Renal and urinary disorders
Hematuria
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Hypersomnia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Vascular disorders
Hypertension
|
61.8%
21/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
28.0%
7/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hyperthyroidism
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
4/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.7%
5/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Endocrine disorders
Hypothyroidism
|
20.6%
7/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Infections & infestations - Other - Flu Symptoms
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Infections & infestations - Other - Muscal
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Infections & infestations - Other - Thrush
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Infections & infestations - Other - Upper Respiratory Infection
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Ear Laceration
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Insomnia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Investigations - Other, specify - Cerebral Edema
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Localized edema
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Lymphocyte count decreased
|
14.7%
5/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Memory impairment
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Diabetes Insipidus
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Liver Function Tests Elevated
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Mucosal infection
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.8%
4/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Muscle weakness left-sided
|
11.8%
4/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
12.0%
3/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Muscle Cramp
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Nausea
|
35.3%
12/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Disease Progression
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Labial Cyst
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other - Tubular Adenoma
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Nervous system - Other - Aphasia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Nervous system - Other - Left 6th Palsy
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Nervous system - Other - Left Eye Ptosis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Nervous system - Other - Right Tongue Deviation
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Neutrophil count decreased
|
14.7%
5/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
General disorders
Pain
|
8.8%
3/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Paresthesia
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Paronychia
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Psychiatric disorders
Personality change
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Platelet count decreased
|
29.4%
10/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
32.0%
8/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
PPE syndrome
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Renal and urinary disorders
Proteinuria
|
20.6%
7/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
28.0%
7/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Tan Phlegm
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Seizure
|
17.6%
6/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Cardiac disorders
Sinus bradycardia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Abrasion
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Lesion, L Upper Arm, L Groin
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Rash, Nos
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Skin infection
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Somnolence
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Stomach pain
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Surgical and medical procedures
Surgical and medical - Other - L True Voal Cord Medialization With Prolaryn Hydroxyapalite
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Surgical and medical procedures
Surgical and medical - Other - Left True Vocal Cord Medialization With Prolaryn Hydroxyapatite
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Surgical and medical procedures
Surgical and medical - Other - Lumbar Radiculopathy
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Nervous system disorders
Tremor
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
2/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Infections and infestations
Urinary tract infection
|
91.2%
31/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Renal and urinary disorders
Urinary urgency
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
8/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Weight gain
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
8.0%
2/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
Weight loss
|
17.6%
6/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
0.00%
0/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Investigations
White blood cell decreased
|
14.7%
5/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
16.0%
4/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/34 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
4.0%
1/25 • Up to 3 years
All participants who receive at least one dose of cediranib, olaparib or bevacizumab will be evaluable for toxicity from the time of their first treatment. Toxicities will be graded via CTCAE 4.0 until March 31, 2018. CTCAE version 5.0 will be utilized for AE reporting beginning April 1, 2018. There were 10 participants in Arm A (cediranib plus olaparib) and 1 participant in Arm B (bevacizumab) that did not receive study treatment, thus were excluded from reporting.
|
Additional Information
Isabel Arillaga-Romany, MD PhD
Massachusetts General Hospital
Phone: 877-442-3324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60