Trial Outcomes & Findings for Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT03414034)
NCT ID: NCT03414034
Last Updated: 2024-11-07
Results Overview
Disease control was defined as lack of prostate-specific antigen (PSA) progression per Prostate Cancer Working Group 3 (PCWG3) criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline up to Week 12
Results posted on
2024-11-07
Participant Flow
A total of 72 participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) were enrolled at 3 investigative sites in the United States between August 2018 and October 2023. Arm A was discontinued with Protocol Version 1.6 (08 Nov 2019). Any participants enrolled and were continuing treatment in Arm A had the opportunity to transition to Arm B (with a re-consent) at the start of their next cycle and at the discretion of the Investigator.
Participant milestones
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
On Day 1 of each cycle, onvansertib was administered orally (PO), once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm B: Onvansertib + Abiraterone and Prednisone
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following dose limiting toxicity (DLT), the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
20
|
28
|
|
Overall Study
Transferred to Arm B
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
20
|
28
|
Reasons for withdrawal
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
On Day 1 of each cycle, onvansertib was administered orally (PO), once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm B: Onvansertib + Abiraterone and Prednisone
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following dose limiting toxicity (DLT), the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Non-compliance With Study Drug
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
3
|
2
|
|
Overall Study
Withdrawal of Informed Consent
|
2
|
1
|
4
|
|
Overall Study
Progressive Disease
|
15
|
15
|
17
|
|
Overall Study
Miscellaneous
|
0
|
0
|
2
|
Baseline Characteristics
Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=24 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=20 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=28 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 8.39 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 8.31 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 12Population: Efficacy Population: comprises all participants who received at least 1 dose of onvansertib at the final recommended dose according to their arm assignments. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Disease control was defined as lack of prostate-specific antigen (PSA) progression per Prostate Cancer Working Group 3 (PCWG3) criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=22 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=20 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=28 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
n=72 Participants
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Disease Control at or Before 12 Weeks
|
13.6 percentage of participants
Interval 5.6 to 29.7
|
50.0 percentage of participants
Interval 12.1 to 87.9
|
35.0 percentage of participants
Interval 20.2 to 53.3
|
35.7 percentage of participants
Interval 22.7 to 51.3
|
29.2 percentage of participants
Interval 21.2 to 38.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 100% Per-protocol (PP) Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
PSA level was measured via blood sample. Mean and standard deviation change is reported.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=8 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=12 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=21 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in PSA at 12 Weeks
|
84.330 percentage of PSA
Standard Deviation 52.545
|
67.064 percentage of PSA
Standard Deviation 50.350
|
42.661 percentage of PSA
Standard Deviation 60.818
|
77.675 percentage of PSA
Standard Deviation 94.611
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
PSA level was measured via blood sample. Mean and standard deviation change is reported.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=8 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=12 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=21 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Mean Absolute Change From Baseline in PSA at 12 Weeks
|
10.904 ng/mL
Standard Deviation 10.141
|
3.095 ng/mL
Standard Deviation 2.199
|
14.971 ng/mL
Standard Deviation 45.023
|
7.295 ng/mL
Standard Deviation 13.076
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 100% Per-protocol (PP) Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
PSA level was measured via blood sample. Median, minimum and maximum change is reported.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=8 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=12 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=21 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Median Percentage Change From Baseline in PSA at 12 Weeks
|
94.814 percentage of PSA
Interval 8.443 to 155.72
|
67.064 percentage of PSA
Interval 31.461 to 102.667
|
25.828 percentage of PSA
Interval -65.823 to 137.069
|
54.630 percentage of PSA
Interval -31.414 to 401.348
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. If a participant did not have a Week 12 (+/- 3 days) PSA measure, then they are not included in this analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
PSA level was measured via blood sample. Median, minimum and maximum change is reported.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=8 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=12 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=21 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Median Absolute Change From Baseline in PSA at 12 Weeks
|
9.110 ng/mL
Interval 0.19 to 26.0
|
3.095 ng/mL
Interval 1.54 to 4.65
|
1.345 ng/mL
Interval -20.8 to 155.0
|
2.300 ng/mL
Interval -5.73 to 47.64
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 100 weeksPopulation: 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with available data are included in the analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Time to PSA progression in weeks is defined as time from Cycle 1 Day 1 (initiation of treatment) until initiation of any PSA progression per PCWG3 criteria: an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL. If a participant discontinued from the study without confirmed PSA progression or death, then they were censored at the last PSA laboratory date. Kaplan-Meier method was used.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=15 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=18 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=25 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Time to PSA Progression or Death
|
5.1 weeks
Interval 3.0 to 9.0
|
10.5 weeks
Interval 3.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
10.9 weeks
Interval 4.0 to 18.0
|
9.0 weeks
Interval 8.0 to 18.0
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 110 weeksPopulation: 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with target or non-target lesions at Baseline are included in the analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Time to radiographic progression in weeks is defined as time from Cycle 1 Day 1 (initiation of treatment) until initiation of any radiographic progression per PCWG3 criteria. If a participant discontinued from the study without confirmed radiographic progression or death, then they were censored at the last valid assessment date.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=15 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=18 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=25 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Time to Radiographic Progression or Death
|
12.0 weeks
Interval 8.6 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
NA weeks
Median and confidence intervals were not calculable due to insufficient events (0).
|
17.4 weeks
Interval 3.9 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
57.0 weeks
Interval 19.1 to 96.1
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with target or non-target lesions at Baseline and at least 1 post-baseline assessment are included. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Radiographic response is defined as the best overall response between Cycle 1 Day 1 and 12 weeks post-baseline being stable disease (SD) or better (partial response \[PR\] or complete response \[CR\]) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1): CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=7 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=8 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=10 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Radiographic Responses at or Before 12 Weeks
|
28.6 percentage of participants
Interval 10.0 to 59.1
|
—
|
62.5 percentage of participants
Interval 34.8 to 83.9
|
80.0 percentage of participants
Interval 54.1 to 93.1
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: 100% PP Population: consists of participants who have been administered 100% of the originally assigned study drugs in at least one full cycle, and without major protocol deviations. Only participants with available data are included in the analysis. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Disease control was defined as lack of PSA progression per PCWG3 criteria: not having an increase in PSA from Baseline or nadir ≥ 25% and ≥ 2 ng/mL during the first 12 weeks of PSA assessments. Participants that do not have 12 weeks of PSA assessments were considered not to have demonstrated PSA progression control in this analysis. If a participant achieved disease control prior to Week 12, but relapsed at, or before Week 12, disease control was still considered achieved. The 90% confidence intervals were calculated using Wilson Confidence Interval.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=15 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=18 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=25 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Are Adherent to Study Treatment (PP Analysis) Achieving Disease Control at or Before 12 Weeks
|
13.3 percentage of participants
Interval 4.5 to 33.4
|
50.0 percentage of participants
Interval 12.1 to 87.9
|
38.9 percentage of participants
Interval 22.7 to 58.0
|
36.0 percentage of participants
Interval 22.3 to 52.4
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 27 monthsPopulation: Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
Adverse events (AEs) are defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as AEs with a start date after Cycle 1 Day 1. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 on a scale from Grade 1 (mild) to Grade 5 (death related to AE).
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=22 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=20 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=28 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAEs
|
22 Participants
|
2 Participants
|
20 Participants
|
27 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAEs with CTCAE Grade ≥3
|
12 Participants
|
0 Participants
|
11 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Arms A and B: up to one 21-day cycle; Arm C: up to two 14-day cyclesPopulation: Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
DLTs are defined as a CTCAE Grade 4 hematologic AE or CTCAE Grade ≥ 3 non-hematologic AE that is considered related to the study drug.
Outcome measures
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=22 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 Participants
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=20 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=28 Participants
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Total
Inclusive of participants enrolled in Arms A, A to B, B, and C.
On Day 1 of each cycle, onvansertib was administered PO, QD. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|---|
|
Number of Participants With DLTs
|
4 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
Adverse Events
Arm A: Onvansertib + Abiraterone and Prednisone
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm A to B: Onvansertib + Abiraterone and Prednisone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B: Onvansertib + Abiraterone and Prednisone
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm C: Onvansertib + Abiraterone and Prednisone
Serious events: 6 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=22 participants at risk
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 participants at risk
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=20 participants at risk
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=28 participants at risk
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Soft tissue infection
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Asthenia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Chest pain
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Pain
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Pyrexia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Seizure
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Syncope
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
Other adverse events
| Measure |
Arm A: Onvansertib + Abiraterone and Prednisone
n=22 participants at risk
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone. This arm was discontinued.
|
Arm A to B: Onvansertib + Abiraterone and Prednisone
n=2 participants at risk
Arm A: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle.
Following discontinuation of Arm A, participants transferred to Arm B: On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol.
Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm B: Onvansertib + Abiraterone and Prednisone
n=20 participants at risk
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Following DLT, the final recommended dose was reduced to 18 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle as pre-specified in the protocol. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
Arm C: Onvansertib + Abiraterone and Prednisone
n=28 participants at risk
On Day 1 of each cycle, onvansertib was administered PO, QD at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants also received abiraterone and prednisone.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial wall thickening
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Anaemia
|
36.4%
8/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
40.0%
8/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
42.9%
12/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
54.5%
12/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
25.0%
5/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
17.9%
5/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Neutropenia
|
36.4%
8/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
40.0%
8/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
17.9%
5/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.7%
5/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
20.0%
4/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
14.3%
4/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
21.4%
6/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Fatigue
|
50.0%
11/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
30.0%
6/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
35.7%
10/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Oedema peripheral
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Chills
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Pyrexia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Asthenia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Malaise
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Hernia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Influenza like illness
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
General disorders
Peripheral swelling
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.6%
3/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
45.0%
9/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
25.0%
7/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
30.0%
6/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
17.9%
5/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
14.3%
4/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
3/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
14.3%
4/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
14.3%
4/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
17.9%
5/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
3/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Urinary tract infection
|
18.2%
4/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Device related infection
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Ear infection
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Nail infection
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
50.0%
1/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
17.9%
5/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Blood creatinine increased
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Blood pressure increased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Electrocardiogram QT prolonged
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Weight decreased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Investigations
Weight increased
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
20.0%
4/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
25.0%
5/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
21.4%
6/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Vascular disorders
Hot flush
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.7%
3/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Vascular disorders
Orthostatic hypotension
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Vascular disorders
Pallor
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
25.0%
5/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
2/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Nocturia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
15.0%
3/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
7.1%
2/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
10.0%
2/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Psychiatric disorders
Depression
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Reproductive system and breast disorders
Penile pain
|
4.5%
1/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
5.0%
1/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
|
Eye disorders
Eye swelling
|
0.00%
0/22 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/2 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
0.00%
0/20 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
3.6%
1/28 • Up to approximately 27 months
Safety Population: comprises all participants who received any dose of onvansertib. Arm A participants who transferred to Arm B and those who did not transfer are summarized separately.
|
Additional Information
Nancy Sherman, Head of Clinical Operations
Cardiff Oncology
Phone: 858-952-7570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place