A Study to Evaluate the Safety and Antitumor Activity in... | NCT01248949

Label	Type	Description	Intervention Names
MEDI3617 SINGLE AGENT TOTAL	Experimental	Participants will receive MEDI3617 via intravenous (IV) infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.	Drug: MEDI3617
MEDI3617 + BEVACIZUMAB Q3W ESCALATION	Experimental	Participants will receive MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.	Drug: MEDI3617 Drug: Bevacizumab
MEDI3617 + BEVACIZUMAB Q2W TOTAL	Experimental	Participants will receive MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.	Drug: MEDI3617 Drug: Bevacizumab
MEDI3617 + PACLITAXEL TOTAL	Experimental	Participants will receive MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.	Drug: MEDI3617

Name	Type	Description	Arm Group Labels	Other Names
MEDI3617	Drug	Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)	DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.	From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
Maximum Tolerated Dose (MTD)	The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.	From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.	From start of study drug administration up to 90 days after the last dose of MEDI3617

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Serum Concentration (Cmax) of MEDI3617	Cmax is the maximum observed serum concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.	Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose

Name	Affiliation	Role
MedImmune, LLC	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Los Angeles	California		United States
Research Site

ID	Title	Description
FG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
FG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose Limiting Toxicities (DLTs)

DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.

DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.

Posted

Number

Participants

From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
OG003	MEDI3617 + PACLITAXEL TOTAL	Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
OG004	MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.

Units	Counts
Participants	OG00023 OG00115 OG00222 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0011 OG0022 OG003

Primary

Maximum Tolerated Dose (MTD)

The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.

Posted

Number

milligram (mg)

From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Primary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.

Safety population included all participants who received treatment with MEDI3617.

Posted

Number

Participants

From start of study drug administration up to 90 days after the last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Primary

Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)

Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.

Safety population included all participants who received treatment with MEDI3617.

Posted

Number

Participants

From start of study drug administration up to 90 days after the last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Primary

Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)

Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.

Safety population included all participants who received treatment with MEDI3617.

Posted

Number

Participants

From start of study drug administration up to 90 days after the last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Primary

Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.

Safety population included all participants who received treatment with MEDI3617.

Posted

Number

Participants

From start of study drug administration up to 90 days after the last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Primary

Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.

Safety population included all participants who received treatment with MEDI3617

Posted

Number

Participants

From start of study drug administration up to 90 days after the last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Secondary

Maximum Observed Serum Concentration (Cmax) of MEDI3617

Cmax is the maximum observed serum concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.

All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

Posted

Mean

Standard Deviation

microgram per milliliter (mcg/ml)

Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Secondary

Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617

AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.

All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

Posted

Mean

Standard Deviation

day*mcg/mL

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Secondary

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617

The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.

All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

Posted

Mean

Standard Deviation

day*mcg/mL

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Secondary

Systemic Clearance (CL) of MEDI3617

Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, "n" is number of participants analyzed for this endpoint at a specific dose.

All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

Posted

Mean

Standard Deviation

milliliter per day (mL/day)

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002

Secondary

Terminal Elimination Half Life (t1/2) of MEDI3617

The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, "n" is number of participants analyzed for this endpoint at a specific dose.

All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.

Posted

Mean

Standard Deviation

day

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Secondary

Number of Participants With Positive Anti-Drug Antibody (ADA)

The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.

All participants who received treatment with MEDI3617.

Posted

Number

participants

Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL

Secondary

Objective Response Rate (ORR)

Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Safety population included all participants who received treatment with MEDI3617.

Posted

Number

Participants

Time from the first dose of investigational product until end of study

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Secondary

Time to Response (TTR)

Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method.

Safety population included all participants who received treatment with MEDI3617.

Posted

Median

Full Range

months

Time from the first dose of investigational product until end of study

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Secondary

Duration of Response (DOR)

Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.

Safety population included all participants who received treatment with MEDI3617.

Posted

Median

Full Range

months

Time from the first dose of investigational product until end of study

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Secondary

Time to Progression (TTP)

Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.

Safety population included all participants who received treatment with MEDI3617.

Posted

Median

Full Range

months

Time from the first dose of investigational product until end of study

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Secondary

Progression-Free Survival (PFS)

PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.

Safety population included all participants who received treatment with MEDI3617.

Posted

Median

Full Range

months

Time from the first dose of investigational product until end of study

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Secondary

Overall Survival (OS)

Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.

Safety population included all participants who received treatment with MEDI3617.

Posted

Median

Full Range

months

Time from the first dose of investigational product until death due to any cause

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.

Secondary

Circulating Levels of Angiopoietin 2 (Ang2)

Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations.

All participants who received treatment with MEDI3617 and for whom PD blood samples were collected and evaluated.

Posted

Mean

Standard Deviation

nanogram per millileter (ng/mL)

Prior to infusion on Cycle 4 and Cycle 5

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.

Primary

Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline

KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.

Safety population included all participants who received treatment with MEDI3617

Posted

Number

Participants

From start of study drug administration up to 30 days after the last dose of MEDI3617

ID	Title	Description
OG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
OG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG0031 events1 affected13 at risk EG0040 events0 affected7 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0003 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0022 events1 affected38 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0010 events0 affected16 at risk EG0022 events1 affected38 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0022 events1 affected38 at risk EG003
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Medical device pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Abscess limb	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Meningitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Blood creatinine increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Troponin increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Weight increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0023 events3 affected38 at risk EG003
Aphasia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Ataxia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0023 events3 affected38 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Seizure	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0022 events2 affected38 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0022 events2 affected38 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected42 at risk EG0013 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Embolism	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Haematoma	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG0032 events2 affected13 at risk EG0043 events2 affected7 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Vision blurred	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected42 at risk EG0012 events2 affected16 at risk EG0023 events3 affected38 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00019 events16 affected42 at risk EG00112 events9 affected16 at risk EG0024 events4 affected38 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00011 events8 affected42 at risk EG0017 events5 affected16 at risk EG0024 events3 affected38 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected42 at risk EG0013 events2 affected16 at risk EG0021 events1 affected38 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0022 events2 affected38 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0012 events2 affected16 at risk EG0021 events1 affected38 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00013 events11 affected42 at risk EG00114 events8 affected16 at risk EG00213 events11 affected38 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00014 events11 affected42 at risk EG0018 events5 affected16 at risk EG0025 events3 affected38 at risk EG003
Chills	General disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected42 at risk EG0011 events1 affected16 at risk EG0023 events3 affected38 at risk EG003
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG00026 events18 affected42 at risk EG00113 events10 affected16 at risk EG00213 events12 affected38 at risk EG003
Mucosal inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0015 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG00015 events11 affected42 at risk EG00112 events2 affected16 at risk EG00216 events7 affected38 at risk EG003
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected42 at risk EG0013 events2 affected16 at risk EG0021 events1 affected38 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0012 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0012 events2 affected16 at risk EG0022 events2 affected38 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0013 events3 affected16 at risk EG0020 events0 affected38 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0011 events1 affected16 at risk EG0022 events2 affected38 at risk EG003
Blood creatinine increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0011 events1 affected16 at risk EG0022 events2 affected38 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG003
Weight increased	Investigations	MedDRA 18.1	Systematic Assessment	EG00011 events8 affected42 at risk EG00115 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00011 events8 affected42 at risk EG0016 events5 affected16 at risk EG0027 events5 affected38 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0012 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0016 events1 affected16 at risk EG0022 events2 affected38 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0008 events3 affected42 at risk EG0010 events0 affected16 at risk EG0023 events2 affected38 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0012 events2 affected16 at risk EG0021 events1 affected38 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0005 events3 affected42 at risk EG0014 events4 affected16 at risk EG0022 events1 affected38 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0012 events2 affected16 at risk EG0022 events2 affected38 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0024 events3 affected38 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0014 events3 affected16 at risk EG0021 events1 affected38 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0012 events2 affected16 at risk EG0023 events3 affected38 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected42 at risk EG0019 events4 affected16 at risk EG0022 events2 affected38 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected42 at risk EG00110 events8 affected16 at risk EG0024 events4 affected38 at risk EG003
Ataxia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0022 events2 affected38 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG00014 events13 affected42 at risk EG00110 events7 affected16 at risk EG0022 events2 affected38 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0008 events7 affected42 at risk EG0016 events4 affected16 at risk EG0028 events7 affected38 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0010 events0 affected16 at risk EG0022 events2 affected38 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected42 at risk EG0012 events2 affected16 at risk EG0025 events3 affected38 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0012 events2 affected16 at risk EG0022 events2 affected38 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0016 events4 affected16 at risk EG0020 events0 affected38 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0014 events3 affected16 at risk EG0020 events0 affected38 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0015 events4 affected16 at risk EG0024 events4 affected38 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0005 events2 affected42 at risk EG0013 events1 affected16 at risk EG00214 events5 affected38 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0009 events9 affected42 at risk EG0015 events4 affected16 at risk EG0023 events2 affected38 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected42 at risk EG0011 events1 affected16 at risk EG0021 events1 affected38 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00012 events9 affected42 at risk EG0014 events3 affected16 at risk EG0024 events4 affected38 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected42 at risk EG0015 events2 affected16 at risk EG0023 events2 affected38 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0012 events2 affected16 at risk EG0021 events1 affected38 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected42 at risk EG0014 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0011 events1 affected16 at risk EG0022 events2 affected38 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0010 events0 affected16 at risk EG0020 events0 affected38 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected42 at risk EG0012 events2 affected16 at risk EG0021 events1 affected38 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0011 events1 affected16 at risk EG0020 events0 affected38 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected42 at risk EG0014 events2 affected16 at risk EG0020 events0 affected38 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected42 at risk EG0010 events0 affected16 at risk EG0021 events1 affected38 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG00012 events10 affected42 at risk EG00124 events6 affected16 at risk EG00216 events13 affected38 at risk EG003

ID	Term
D010051	Ovarian Neoplasms
D005910	Glioma

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes

ID	Title	Description
BG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
BG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
BG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
BG003	MEDI3617 + PACLITAXEL TOTAL	Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
BG004	MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
BG005	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MEDI3617 SINGLE AGENT TOTAL	Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.	18	42	40	42
EG001	MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.	4	16	16	16
EG002	MEDI3617 + BEVACIZUMAB Q2W TOTAL	Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.	18	38	34	38
EG003	MEDI3617 + PACLITAXEL TOTAL	Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.	7	13	13	13
EG004	MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL	Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.	4	7	7	7

ID	Term
C573120	MEDI3617
D000068258	Bevacizumab
D017239	Paclitaxel
D016190	Carboplatin