Bintrafusp Alfa Combination Therapy in Participants With... | NCT04551950

ID	Type	Description	Link
2020-001561-36	EudraCT Number

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Label	Type	Intervention Names
Cohort 1A:M7824+Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Experimental	Drug: M7824 Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab Drug: Cisplatin
Cohort1B:M7824+Cisplatin or Carboplatin+Paclitaxel	Experimental	Drug: M7824 Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin
Cohort 2: M7824+Cisplatin+ Radiotherapy	Experimental	Drug: M7824 Drug: Cisplatin Radiation: Radiotherapy

Name	Type	Description	Arm Group Labels	Other Names
M7824	Drug	Participants received bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).

Measure	Description	Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs)	DLT was defined as Adverse Events (AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to (>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting >= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for >= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (<) 1,000/mm3 with a temperature of > 38.3 degree Celsius (°C); grade 4 is defined as ANC < 1,000/mm3 with a temperature of > 38.3°C, with life-threatening consequences; Thrombocytopenia < 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events >= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay (> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.	Up to 4 weeks after first administration of study intervention
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as events with onset date or worsening during the on-treatment period. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included serious TEAEs and non-serious TEAEs.	Time from first treatment assessed up to approximately 20 months

Measure	Description	Time Frame
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa	Ceoi was the observed concentration at the end of the infusion period. This was taken directly from the observed Bintrafusp Alfa concentration-time data.	Pre-dose Up to 20 months
Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria for participants enrolling into Cohort 1:
Study participants had documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Study participants had not been treated with systemic chemotherapy and were not amenable to curative treatment
Prior radiation with or without radio-sensitizing chemotherapy was allowed
Inclusion Criteria for participants enrolling into Cohort 2:
Participants had documented evidence of cervical adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages 1B2 to 4A
Participants had not received prior chemotherapy or radiotherapy for cervical cancer
Inclusion Criteria for all participants:
Archival tumor tissue sample or newly obtained core or excisional biopsy was required
Participants who had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 to 1 were eligible
Participants had a life expectancy greater than or equal to 12 weeks
Participants had adequate hematological, hepatic, renal, and coagulation function as defined in the protocol
Participants with known Human immunodeficiency virus (HIV) infections were eligible if the criteria described in the protocol were met
Participants with Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) infections were eligible if the criteria described in the protocol were met
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Exclusion Criteria for All Participants were:
Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that required therapeutic intervention were excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) were not eligible unless they had fully recovered from treatment, demonstrated no progression for at least 4 weeks, and were not using steroids for at least 7 days prior to the start of study intervention
Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that did not require immuno-suppression
Participants with significant acute or chronic infections
Participants with active autoimmune disease that might have deteriorated when receiving an immuno-stimulatory agent
Participants with clinically significant cardiovascular/cerebrovascular disease including: a cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
Participants with a history of bleeding diathesis or recent major bleeding events
Participant that had received prior cancer treatment with any other immunotherapy or checkpoint inhibitors or any other immune-modulating monoclonal antibody (mAb)
Exclusion Criteria for Participants in Cohort 1A related to use of bevacizumab were:
Participants with inadequately controlled hypertension
Prior history of hypertensive crisis or hypertensive encephalopathy
Participants with significant vascular disease within 6 months prior to Screening
Participants with a history of hemoptysis within 1 month prior to Screening
Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
Participants with a history of abdominal or trache-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Screening
Participants with clinical signs of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
Participants with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Participants with serious, non-healing wound, active ulcer, or untreated bone fracture
Participants with proteinuria
Other protocol defined exclusion criteria could apply

Name	Affiliation	Role
Medical Responsible	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Health Care Hospital & Clinics		Stanford	California	94305	United States
Augusta University - formerly Georgia Regents University

Label	URL
Trial Awareness and Transparency website	View source
US Medical Information website, Medical Resources	View source

ID	Title	Description
FG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 6, 2021	Jul 31, 2023

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 Adverse Events (AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to (>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting >= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for >= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (<) 1,000/mm3 with a temperature of > 38.3 degree Celsius (°C); grade 4 is defined as ANC < 1,000/mm3 with a temperature of > 38.3°C, with life-threatening consequences; Thrombocytopenia < 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events >= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay (> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity.

Dose-Limiting Toxicity Analysis (DLT) Set included all participants who completed the DLT period (within 4 weeks after first administration of study intervention) with at least 80 Percent (%) of the planned cumulative dose received during this period for each study intervention and/or who experienced at least one DLT during the DLT period.

Posted

Count of Participants

Participants

Up to 4 weeks after first administration of study intervention

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Units	Counts
Participants	OG0008 OG0019 OG0028

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0012 OG0020

Primary

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

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as events with onset date or worsening during the on-treatment period. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included serious TEAEs and non-serious TEAEs.

The safety (SAF) analysis set included all participants who were administered any dose of any study intervention.

Posted

Count of Participants

Participants

Time from first treatment assessed up to approximately 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

Secondary

Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa

Ceoi was the observed concentration at the end of the infusion period. This was taken directly from the observed Bintrafusp Alfa concentration-time data.

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Secondary

Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa

Ctrough was the serum concentration observed immediately before next dosing.

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Secondary

Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Bintrafusp Alfa

The area under the concentration-time curve (AUC) from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy

Secondary

Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp Alfa

AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

Secondary

Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa

Cmax was obtained directly from the concentration versus time curve.

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Secondary

Time to Reach Maximum Serum Concentration (Tmax) of Bintrafusp Alfa

The time to reach the maximum observed concentration collected during a dosing interval. Tmax was obtained directly from the concentration versus time curve.

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Secondary

Terminal Elimination Half-Life (T1/2) of Bintrafusp Alfa

Elimination Half Life (T1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. Elimination half-life determined as 0.693/ Lamda z(λz), λz=terminal first order (elimination) rate constant.

As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Secondary

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

A validated method was applied to detect ADAs in the presence of drug in human serum. The ADA titers of positive samples were determined.

As per changes in planned analysis, the outcome measure related to immunogenicity were not assessed.

Posted

Pre-dose Up to 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.

Secondary

Number of Japanese Participants With Dose-Limiting Toxicities (DLTs)

Posted

Count of Participants

Participants

Up to 4 weeks after first administration of study intervention

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

Secondary

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

The safety (SAF) analysis set included all participants who were administered any dose of any study intervention. Number of Participants Analyzed=participants evaluable for this outcome.

Posted

Count of Participants

Participants

Time from first treatment assessed up to approximately 20 months

ID	Title	Description
OG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
OG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Non-systematic Assessment	EG0006 affected8 at risk EG0017 affected9 at risk EG0025 affected8 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Palpitations	Cardiac disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hypothyroidism	Endocrine disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Diplopia	Eye disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Vision blurred	Eye disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0004 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0012 affected9 at risk EG0023 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0015 affected9 at risk EG0028 affected8 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Gastritis	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0013 affected9 at risk EG0022 affected8 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Melaena	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0016 affected9 at risk EG0026 affected8 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0013 affected9 at risk EG0021 affected8 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0014 affected9 at risk EG0024 affected8 at risk
Asthenia	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Catheter site pain	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Chest discomfort	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Chills	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Fatigue	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Gait disturbance	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Infusion site extravasation	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Injection site pain	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Malaise	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Oedema peripheral	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pyrexia	General disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Coronavirus infection	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Cystitis	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Gingivitis	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Infected dermal cyst	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Infection	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Pelvic abscess	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Skin infection	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Tinea pedis	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Tonsillitis	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0000 events0 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0013 affected9 at risk EG0021 affected8 at risk
Uterine abscess	Infections and infestations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Urinary tract stoma complication	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0013 affected9 at risk EG0020 affected8 at risk
Amylase increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0014 affected9 at risk EG0021 affected8 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Blood creatinine increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
C-reactive protein increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Lipase increased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Lymphocyte count decreased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Neutrophil count decreased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Platelet count decreased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0013 affected9 at risk EG0022 affected8 at risk
Weight decreased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0022 affected8 at risk
White blood cell count decreased	Investigations	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0024 affected8 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0014 affected9 at risk EG0020 affected8 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0013 affected9 at risk EG0020 affected8 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Dysaesthesia	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Dysgeusia	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0011 affected9 at risk EG0023 affected8 at risk
Facial paralysis	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Headache	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0013 affected9 at risk EG0023 affected8 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Neurotoxicity	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0014 affected9 at risk EG0020 affected8 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Presyncope	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Radiculopathy	Nervous system disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Thrombosis in device	Product Issues	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Anxiety	Psychiatric disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0022 affected8 at risk
Insomnia	Psychiatric disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Mania	Psychiatric disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Mood swings	Psychiatric disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Dysuria	Renal and urinary disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Haematuria	Renal and urinary disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Proteinuria	Renal and urinary disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0022 affected8 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0013 affected9 at risk EG0022 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0004 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk EG0021 affected8 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0015 affected9 at risk EG0020 affected8 at risk
Asteatosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0003 affected8 at risk EG0010 affected9 at risk EG0022 affected8 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0012 affected9 at risk EG0022 affected8 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0002 affected8 at risk EG0013 affected9 at risk EG0024 affected8 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0013 affected9 at risk EG0022 affected8 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0013 affected9 at risk EG0023 affected8 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected9 at risk EG0020 affected8 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Skin texture abnormal	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Menopause	Social circumstances	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected8 at risk
Arteriosclerosis	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Embolism	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Flushing	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Hot flush	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected8 at risk
Hypotension	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk
Lymphoedema	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0021 affected8 at risk
Phlebitis	Vascular disorders	MedDRA 25.0	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected8 at risk

ID	Term
D002583	Uterine Cervical Neoplasms
D003966	Camurati-Engelmann Syndrome

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D010009	Osteochondrodysplasias
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes
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
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D013812	Therapeutics

ID	Title	Description
BG000	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
BG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
BG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.
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	Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab	Participants received 2400 miligrams (mg) Bintrafusp alfa along with 50 milligram per square meter (mg/m^2) Cisplatin or Carboplatin, Paclitaxel and 15 milligram per kilogram (mg/kg) Bevacizumab every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.	2	8	7	8	8	8
EG001	Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel	Participants received 2400 mg Bintrafusp alfa along with 50 mg/m^2 Cisplatin or Carboplatin, 175 mg/m^2 Paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.	2	9	4	9	9	9
EG002	Cohort 2: Bintrafusp Alfa + Cisplatin+ Radiotherapy	Participants received 2400 mg Bintrafusp alfa once every 3 weeks along with 40 mg/m^2 Cisplatin weekly for 5 weeks followed by radiotherapy as per standard care.	0	8	6	8	8	8

ID	Term
C000723824	bintrafusp alfa protein, human
D016190	Carboplatin
D017239	Paclitaxel
D000068258	Bevacizumab
D002945	Cisplatin
D011878	Radiotherapy