NCT03660826 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).
What was measured
Overall survival is defined as the time from the date of study enrollment to the date of death regardless of cause. For those individuals who have no death reported at the time of the analysis, the censored time at risk will be assessed from the date of study enrollment to the date that the patient was last contacted and known to be alive.
Analysis population: All patients randomized (Intent-to-Treat)
Groups in this outcome
Arm I (Cediranib maleate_Referenc Group 1)
Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
Arm II (Olaparib)
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
Arm III (Cediranib Maleate, Olaparib)
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
Arm IV (Olaparib, Capivasertib)
Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
Arm V (Olaparib, Durvalumab)
Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
Arm VI (Cediranib Maleate, Durvalumab)
Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
Arm VII (Cediranib maleate_Reference Group 2)
Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
| Group | Source count |
|---|---|
| Arm I (Cediranib maleate_Referenc Group 1) | 40 |
| Arm II (Olaparib) | 40 |
| Arm III (Cediranib Maleate, Olaparib) | 40 |
| Arm IV (Olaparib, Capivasertib) | 42 |
| Arm V (Olaparib, Durvalumab) | 42 |
| Arm VI (Cediranib Maleate, Durvalumab) | 43 |
| Arm VII (Cediranib maleate_Reference Group 2) | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Cediranib maleate_Referenc Group 1) | 12.4 | Not reported | 7.5 | 22.9 | Not reported |
| Arm II (Olaparib) | 13.4 | Not reported | 6.5 | 19.5 | Not reported |
| Arm III (Cediranib Maleate, Olaparib) | 17.6 | Not reported | 9.3 | 21.2 | Not reported |
| Arm IV (Olaparib, Capivasertib) | 16.9 | Not reported | 9.3 | 20.3 | Not reported |
| Arm V (Olaparib, Durvalumab) | 14.0 | Not reported | 10.4 | 20.3 | Not reported |
| Arm VI (Cediranib Maleate, Durvalumab) | 22.6 | Not reported | 13.1 | NA | The number of events was not sufficient for the estimation of this parameter (i.e. upper limit of the CI) |
| Arm VII (Cediranib maleate_Reference Group 2) | 16.6 | Not reported | 8.5 | 20.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- 22.9
- value
- 12.4
- group Id
- OG001
- lower Limit
- 6.5
- upper Limit
- 19.5
- value
- 13.4
- group Id
- OG002
- lower Limit
- 9.3
- upper Limit
- 21.2
- value
- 17.6
- group Id
- OG003
- lower Limit
- 9.3
- upper Limit
- 20.3
- value
- 16.9
- group Id
- OG004
- lower Limit
- 10.4
- upper Limit
- 20.3
- value
- 14.0
- comment
- The number of events was not sufficient for the estimation of this parameter (i.e. upper limit of the CI)
- group Id
- OG005
- lower Limit
- 13.1
- upper Limit
- NA
- value
- 22.6
- group Id
- OG006
- lower Limit
- 8.5
- upper Limit
- 20.6
- value
- 16.6
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 40
- group Id
- OG003
- value
- 42
- group Id
- OG004
- value
- 42
- group Id
- OG005
- value
- 43
- group Id
- OG006
- value
- 41
- units
- Participants
- description
- Overall survival is defined as the time from the date of study enrollment to the date of death regardless of cause. For those individuals who have no death reported at the time of the analysis, the censored time at risk will be assessed from the date of study enrollment to the date that the patient was last contacted and known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
- id
- OG000
- title
- Arm I (Cediranib maleate_Referenc Group 1)
- description
- Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
- id
- OG001
- title
- Arm II (Olaparib)
- description
- Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
- id
- OG002
- title
- Arm III (Cediranib Maleate, Olaparib)
- description
- Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
- id
- OG003
- title
- Arm IV (Olaparib, Capivasertib)
- description
- Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
- id
- OG004
- title
- Arm V (Olaparib, Durvalumab)
- description
- Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
- id
- OG005
- title
- Arm VI (Cediranib Maleate, Durvalumab)
- description
- Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
- id
- OG006
- title
- Arm VII (Cediranib maleate_Reference Group 2)
- param Type
- MEDIAN
- population Description
- All patients randomized (Intent-to-Treat)
- reporting Status
- POSTED
- time Frame
- Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice
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