NCT03660826 · ADVERSE EVENTS

Adverse events

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone · Source last updated 2026-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months.
Other-event reporting threshold: 0%

Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Cediranib maleate_Reference 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	17 / 39	38 / 39	23 / 40
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	12 / 40	40 / 40	26 / 40
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	19 / 39	39 / 39	20 / 40
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	11 / 42	41 / 42	27 / 42
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	16 / 42	42 / 42	28 / 42
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	13 / 42	40 / 42	21 / 43
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 MUG	19 / 37	37 / 37	27 / 41

Group identifiers: EG000: Arm I (Cediranib maleate_Reference Group 1) · EG001: Arm II (Olaparib) · EG002: Arm III (Cediranib Maleate, Olaparib) · EG003: Arm IV (Olaparib, Capivasertib) · EG004: Arm V (Olaparib, Durvalumab) · EG005: Arm VI (Cediranib Maleate, Durvalumab) · EG006: Arm VII (Cediranib maleate_Reference Group 2)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
2
num At Risk
37
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Colonic Fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Small Intestinal Perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Rectal Hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Colonic Obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Small Intestinal Obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Nausea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
12
num At Risk
39
group Id
EG001
num Affected
27
num At Risk
40
group Id
EG002
num Affected
10
num At Risk
39
group Id
EG003
num Affected
24
num At Risk
42
group Id
EG004
num Affected
21
num At Risk
42
group Id
EG005
num Affected
11
num At Risk
42
group Id
EG006
num Affected
5
num At Risk
37
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Eosinophilia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Lymph Node Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
2
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
2
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Blood And Lymphatic System Disorders - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Left Ventricular Systolic Dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Pericardial Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Supraventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Sinus Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Myocardial Infarction

Complete source fields

description

Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.

event Groups

deaths Num Affected
23
deaths Num At Risk
40
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
EG000
other Num Affected
38
other Num At Risk
39
serious Num Affected
17
serious Num At Risk
39
title
Arm I (Cediranib maleate_Reference Group 1)
deaths Num Affected
26
deaths Num At Risk
40
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
EG001
other Num Affected
40
other Num At Risk
40
serious Num Affected
12
serious Num At Risk
40
title
Arm II (Olaparib)
deaths Num Affected
20
deaths Num At Risk
40
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
EG002
other Num Affected
39
other Num At Risk
39
serious Num Affected
19
serious Num At Risk
39
title
Arm III (Cediranib Maleate, Olaparib)
deaths Num Affected
27
deaths Num At Risk
42
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
EG003
other Num Affected
41
other Num At Risk
42
serious Num Affected
11
serious Num At Risk
42
title
Arm IV (Olaparib, Capivasertib)
deaths Num Affected
28
deaths Num At Risk
42
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
EG004
other Num Affected
42
other Num At Risk
42
serious Num Affected
16
serious Num At Risk
42
title
Arm V (Olaparib, Durvalumab)
deaths Num Affected
21
deaths Num At Risk
43
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
EG005
other Num Affected
40
other Num At Risk
42
serious Num Affected
13
serious Num At Risk
42
title
Arm VI (Cediranib Maleate, Durvalumab)
deaths Num Affected
27
deaths Num At Risk
41
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 MUG
id
EG006
other Num Affected
37
other Num At Risk
37
serious Num Affected
19
serious Num At Risk
37
title
Arm VII (Cediranib maleate_Reference Group 2)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
12
num At Risk
39
group Id
EG001
num Affected
27
num At Risk
40
group Id
EG002
num Affected
10
num At Risk
39
group Id
EG003
num Affected
24
num At Risk
42
group Id
EG004
num Affected
21
num At Risk
42
group Id
EG005
num Affected
11
num At Risk
42
group Id
EG006
num Affected
5
num At Risk
37
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Eosinophilia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Lymph Node Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
2
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
2
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Blood And Lymphatic System Disorders - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Left Ventricular Systolic Dysfunction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Pericardial Effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Supraventricular Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Sinus Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Myocardial Infarction

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
2
num At Risk
37
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Colonic Fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
1
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Small Intestinal Perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
1
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Rectal Hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
1
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Colonic Obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
1
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
0
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
1
num At Risk
37
term
Small Intestinal Obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
39
group Id
EG001
num Affected
0
num At Risk
40
group Id
EG002
num Affected
0
num At Risk
39
group Id
EG003
num Affected
0
num At Risk
42
group Id
EG004
num Affected
1
num At Risk
42
group Id
EG005
num Affected
0
num At Risk
42
group Id
EG006
num Affected
0
num At Risk
37
term
Nausea

time Frame

Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months.

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Preserved source evidence · Not medical advice