Safety and Efficacy of MEDI0457 and Durvalumab in Partici... | NCT03162224

Label	Type	Description	Intervention Names
First-line Recurrent/Metastatic (1L R/M) Platinum Non-refractory	Experimental	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then every 8 weeks (Q8W) and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then every 4 weeks (Q4W) until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first.	Drug: MEDI0457 Device: CELLECTRA®5P device Drug: Durvalumab
1L R/M Platinum Refractory	Experimental	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first.	Drug: MEDI0457 Device: CELLECTRA®5P device Drug: Durvalumab
Second-line (2L) + R/M	Experimental	Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, will receive MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first.	Drug: MEDI0457 Device: CELLECTRA®5P device Drug: Durvalumab

Name	Type	Description	Arm Group Labels	Other Names
MEDI0457	Drug	MEDI0457 7 mg will be administered intramuscularly followed by electroporation (EP) using CELLECTRA®5P device.	1L R/M Platinum Refractory First-line Recurrent/Metastatic (1L R/M) Platinum Non-refractory

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measures at the time of end of study.	Day 1 through 90 days after the last dose of study drug (approximately 45 months)
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs	Any laboratory abnormality during analysis of hematology, clinical chemistry, thyroid function tests, and urinalysis that was new in onset or worsened in severity or frequency from the baseline condition and required therapeutic intervention or diagnostic tests, led to discontinuation of study treatment, had accompanying or inducing symptoms or signs, or judged by the Investigator as clinically significant was recorded as AE. Participants with abnormal laboratory parameters reported as TEAEs are reported.	Day 1 through 90 days after the last dose of study drug (approximately 45 months)
Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs	Participants with ECG abnormalities reported as TEAEs are reported.	Day 1 through 90 days after the last dose of study drug (approximately 45 months)
Number of Participants With Abnormal Vital Signs and/or Physical Examination Reported as TEAEs	Vital sign assessment included body temperature, respiration rate, pulse oximetry, blood pressure, heart rate, and weight. Participants with abnormal vital sign and/or abnormal physical examination reported as TEAEs are reported.

Measure	Description	Time Frame
Percentage of Participants With Objective Response by RECIST Version 1.1 in As-treated Population	The objective response is defined as confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.

Name	Affiliation	Role
MedImmune LLC	Study Director	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		San Francisco	California	94115	United States
Research Site

Label	URL
D8860C00005 SAP redacted	View source
CSP Redacted	View source

ID	Title	Description
FG000	First-line Recurrent/Metastatic (1L R/M) Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then every 8 weeks (Q8W) and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then every 4 weeks (Q4W) until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 17, 2021	Aug 3, 2022

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 Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measures at the time of end of study.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

Day 1 through 90 days after the last dose of study drug (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG002	2L+R/M	Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Units	Counts
Participants	OG00015 OG0019 OG00211

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG00015 OG0019 OG00211

Any TESAE

Primary

Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs

Any laboratory abnormality during analysis of hematology, clinical chemistry, thyroid function tests, and urinalysis that was new in onset or worsened in severity or frequency from the baseline condition and required therapeutic intervention or diagnostic tests, led to discontinuation of study treatment, had accompanying or inducing symptoms or signs, or judged by the Investigator as clinically significant was recorded as AE. Participants with abnormal laboratory parameters reported as TEAEs are reported.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

Day 1 through 90 days after the last dose of study drug (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Primary

Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs

Participants with ECG abnormalities reported as TEAEs are reported.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

Day 1 through 90 days after the last dose of study drug (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG002	2L+R/M

Primary

Number of Participants With Abnormal Vital Signs and/or Physical Examination Reported as TEAEs

Vital sign assessment included body temperature, respiration rate, pulse oximetry, blood pressure, heart rate, and weight. Participants with abnormal vital sign and/or abnormal physical examination reported as TEAEs are reported.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

Day 1 through 90 days after the last dose of study drug (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Primary

Number of Participants Who Received Any Concomitant Medications During the Study

Participants who received concomitant medications which were ongoing at the start of treatment or started after the study treatment are included.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

Day 1 through 90 days after the last dose of study drug (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG002

Primary

Number of Participants With Shift >=3 Changed From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status

Participants with shift >=3 changed from baseline in ECOG status are reported. ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. The scores are: 0 = Fully Active, able to carry out all pre-disease performance without restrictions; 1 = Restricted activity but ambulatory and able to carry out light work or work of a sedentary nature; 2 = Ambulatory and capable of self-care but unable to carry out work activities; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely Disabled, unable to carry out any self-care and totally confined to bed or chair; 5 = Dead.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Count of Participants

Participants

Day 1 through 90 days after the last dose of study drug (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Primary

Percentage of Participants With Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Response-evaluable Population

The objective response is defined as confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.

Response-evaluable population included all participants with confirmed human papilloma virus Type 16 (HPV-16) or HPV-18 associated disease, who received one dose of both study drugs, had a baseline scan (Days -28 to -1) with measurable disease at baseline, and at least one follow-up scan with the opportunity to be followed for >= 16 weeks.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 1 through end of study (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

Percentage of Participants With Objective Response by RECIST Version 1.1 in As-treated Population

The objective response is defined as confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 1 through end of study (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

Percentage of Participants With Objective Response by Immune-related RECIST (irRECIST) in Response-evaluable Population

The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 50% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed irCR or irPR is defined as 2 irCRs or 2 irPRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. Percentage of participants with objective response is reported.

Response-evaluable population included all participants with confirmed HPV-16 or HPV-18 associated disease, who received one dose of both study drugs, had a baseline scan (Days -28 to -1) with measurable disease at baseline, and at least one follow-up scan with the opportunity to be followed for >= 16 weeks.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 1 through end of study (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

Percentage of Participants With Objective Response by irRECIST in As-treated Population

As-treated population included all participants who received at least one dose of any study drug.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 1 through end of study (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

Disease Control Rate (DCR) at Week 16 by RECIST Version 1.1 in Response-evaluable Population

The DCR is defined percentage of participants with CR, PR, or stable disease (SD) at 16 weeks based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline and no new non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s) or / and maintenance of tumor marker level above the normal limits.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 16

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

DCR at Week 16 by RECIST Version 1.1 in As-treated Population

The DCR is defined percentage of participants with CR, PR, or SD at 16 weeks based on RECIST v1.1 guidelines. A CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. A PR is defined as >= 30% decrease in the sum of longest diameters of target lesions compared to baseline and no new non-target lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum longest diameter since the study treatment started, and persistence of one or more non-target lesion(s) or / and maintenance of tumor marker level above the normal limits.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 16

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory

Secondary

Progression Free Survival (PFS)

The PFS is defined as the time from the date of start of study treatment until the documentation of disease progression based on RECIST version 1.1 or death due to any cause, whichever occurs first. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who were not progressed or died at the time of the analysis were censored at the time of the latest date of assessment from their last evaluable RECIST version 1.1 assessment. The PFS was estimated using Kaplan-Meier method.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Median

95% Confidence Interval

Months

Day 1 through end of study (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory

Secondary

Overall Survival (OS)

Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.

As-treated population included all participants who received at least one dose of any study drug.

Posted

Median

95% Confidence Interval

Months

Day 1 through end of study (approximately 45 months)

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab

Number of participants with positive ADA titer to durvalumab are reported. ADA prevalence is defined as ADA positive at any point (baseline and post-baseline); persistent positive is defined as ADA positive at Week 16, and transient positive is defined as positive at Week 8 but not at Week 16, regardless of baseline positivity.

The ADA evaluable population included all participants who had non-missing baseline ADAs (on Day 1) and at least one non-missing post-baseline ADA result.

Posted

Count of Participants

Participants

Pre-dose (up to 60 minutes prior to durvalumab administration) on Week 4, Week 8, and Week 16

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Secondary

Serum Concentrations of Durvalumab

Serum concentrations of durvalumab is reported.

Pharmacokinetics population included all participants who received at least one dose of durvalumab and had at least one evaluable post-dose serum concentration measurement of durvalumab. 'Number analyzed' denotes the number of participants evaluated for the specified time point.

Posted

Mean

Standard Deviation

mg/L

Pre-dose (up to 60 minutes prior to durvalumab administration) on Week 4, Week 8, and Week 16

ID	Title	Description
OG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
OG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Left ventricular hypertrophy	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Incision site erythema	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Osteoradionecrosis	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Myocarditis	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events1 affected9 at risk EG0021 events1 affected11 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected9 at risk EG0021 events1 affected11 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0022 events2 affected11 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0017 events5 affected9 at risk EG0028 events4 affected11 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0012 events2 affected9 at risk EG0022 events2 affected11 at risk
Cataract	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Corneal thinning	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Ocular hyperaemia	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Retinal detachment	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0022 events1 affected11 at risk
Retinal tear	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Vision blurred	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Visual impairment	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0022 events1 affected11 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0023 events1 affected11 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events3 affected9 at risk EG0023 events3 affected11 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 events2 affected15 at risk EG0016 events2 affected9 at risk EG0029 events2 affected11 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Lip dry	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected15 at risk EG0014 events2 affected9 at risk EG0023 events3 affected11 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0014 events3 affected9 at risk EG0021 events1 affected11 at risk
Administration site bruise	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Administration site induration	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Administration site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0007 events2 affected15 at risk EG0012 events1 affected9 at risk EG0028 events1 affected11 at risk
Administration site reaction	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Administration site swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Catheter site pruritus	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0023 events1 affected11 at risk
Chills	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Face oedema	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected9 at risk EG0021 events1 affected11 at risk
Facial pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG00016 events9 affected15 at risk EG0016 events6 affected9 at risk EG0024 events4 affected11 at risk
Fibrosis	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Gait disturbance	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Influenza like illness	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Injection site discomfort	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Injection site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG00012 events4 affected15 at risk EG00113 events4 affected9 at risk EG0021 events1 affected11 at risk
Injection site swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Localised oedema	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0003 events1 affected15 at risk EG0011 events1 affected9 at risk EG0022 events1 affected11 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0004 events3 affected15 at risk EG0010 events0 affected9 at risk EG0023 events2 affected11 at risk
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0014 events4 affected9 at risk EG0022 events2 affected11 at risk
Swelling face	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Vaccination site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Conjunctivitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Bradycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0023 events3 affected11 at risk
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Epididymitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Hordeolum	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Kidney infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Laryngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Oral herpes	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk
Oral infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Pilonidal cyst	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Wound infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events1 affected9 at risk EG0021 events1 affected11 at risk
Amylase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0015 events1 affected9 at risk EG0023 events3 affected11 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0022 events1 affected11 at risk
Blood bilirubin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events1 affected9 at risk EG0020 events0 affected11 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0023 events1 affected11 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Blood pressure increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0022 events1 affected11 at risk
Blood urea increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Breath sounds abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Lipase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Lymphocyte count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0007 events2 affected15 at risk EG0013 events1 affected9 at risk EG0027 events3 affected11 at risk
Neutrophil count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Platelet count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Red blood cell count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Tri-iodothyronine decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Troponin t increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Weight decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected15 at risk EG0013 events2 affected9 at risk EG0026 events2 affected11 at risk
Weight increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
White blood cell count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0022 events1 affected11 at risk
White blood cell count increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0011 events1 affected9 at risk EG0023 events2 affected11 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0011 events1 affected9 at risk EG0026 events1 affected11 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0024 events2 affected11 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0016 events3 affected9 at risk EG0021 events1 affected11 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0015 events3 affected9 at risk EG0022 events2 affected11 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected15 at risk EG00111 events2 affected9 at risk EG0023 events2 affected11 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0014 events2 affected9 at risk EG0024 events4 affected11 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0005 events2 affected15 at risk EG0012 events1 affected9 at risk EG0021 events1 affected11 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0016 events2 affected9 at risk EG0025 events3 affected11 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected9 at risk EG0021 events1 affected11 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Accessory nerve disorder	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events2 affected9 at risk EG0022 events2 affected11 at risk
Dizziness postural	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0014 events3 affected9 at risk EG0021 events1 affected11 at risk
Memory impairment	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Migraine	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Muscle spasticity	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk
Presyncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events1 affected9 at risk EG0020 events0 affected11 at risk
Taste disorder	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Tremor	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Device leakage	Product Issues	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Agitation	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Anxiety	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0004 events3 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Confusional state	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Depression	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Insomnia	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk
Sleep disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Dysuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Nocturia	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Scrotal erythema	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0007 events5 affected15 at risk EG0016 events4 affected9 at risk EG0028 events7 affected11 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0012 events1 affected9 at risk EG0021 events1 affected11 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected15 at risk EG0015 events4 affected9 at risk EG0024 events3 affected11 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 events2 affected15 at risk EG0011 events1 affected9 at risk EG0022 events2 affected11 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0023 events1 affected11 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events1 affected9 at risk EG0021 events1 affected11 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events3 affected9 at risk EG0020 events0 affected11 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0014 events1 affected9 at risk EG0020 events0 affected11 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0008 events2 affected15 at risk EG0014 events2 affected9 at risk EG0020 events0 affected11 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected15 at risk EG0013 events3 affected9 at risk EG0021 events1 affected11 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Eye irritation	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Reactive perforating collagenosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Aortic aneurysm	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Hot flush	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0008 events5 affected15 at risk EG0013 events1 affected9 at risk EG00211 events4 affected11 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk
Lymphoedema	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk
Thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Eye swelling	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0013 events2 affected9 at risk EG0022 events2 affected11 at risk
Eructation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Flatulence	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Mouth swelling	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Candida infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk
Oral candidiasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected9 at risk EG0022 events2 affected11 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk

ID	Term
D006258	Head and Neck Neoplasms
D000077195	Squamous Cell Carcinoma of Head and Neck
D009959	Oropharyngeal Neoplasms
D012008	Recurrence
D009362	Neoplasm Metastasis
D009369	Neoplasms

ID	Term
D009371	Neoplasms by Site
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases
D010038	Otorhinolaryngologic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009385	Neoplastic Processes

ID	Title	Description
BG000	1L R/M Platinum Non-refractory	Participants with recurrent or metastatic disease and were non-refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
BG001	1L R/M Platinum Refractory	Participants with R/M disease and were refractory to neoadjuvant/adjuvant platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
BG002	2L+R/M	Participants with R/M disease and were treated with 1 or more lines of platinum based chemotherapy, received MEDI0457 7 mg intramuscularly followed by electroporation on Day 1 of Weeks 1, 3, 7, 12, and then Q8W and durvalumab 1500 mg intravenously on Day 1 of Week 4 and then Q4W until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1L R/M Platinum Non-refractory	Description (Arm-group)	4	15	4	15	15	15
EG001	1L R/M Platinum Refractory	Description (Arm-group)	5	9	4	9	9	9
EG002	2L+ R/M	Description (Arm-group)	8	11	6	11	11	11