Tusamitamab Ravtansine (SAR408701) in Combination With Ra... | NCT05071053

ID	Type	Description	Link
U1111-1266-5040	Registry Identifier	ICTRP
2021-001967-26	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tusamitamab ravtansine+Ramucirumab	Experimental	Participants received ramucirumab 8 milligram/kilogram (mg/kg) via intravenous (IV) infusion followed by tusamitamab ravtansine loading dose at 170 mg/meter square (m^2) via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 and every 2 weeks (Q2W) in all subsequent cycles until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.	Drug: Ramucirumab (CYRAMZA®) Drug: Tusamitamab ravtansine (SAR408701)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramucirumab (CYRAMZA®)	Drug	Pharmaceutical Form: Concentrate for solution for infusion Route of Administration: Intravenous Infusion	Tusamitamab ravtansine+Ramucirumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs)	The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: Grade 4 neutropenia for 7 or more consecutive days. Grade 3 to 4 neutropenia complicated by fever (temperature >=38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection. Grade >=3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention. Grade 4 non-hematologic AE. Grade >=3 keratopathy. In addition, any other AE that the Investigators and sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT.	From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days
Objective Response Rate (ORR)	The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma
Metastatic disease or locally advanced, unresectable disease
Participants who have measurable target lesion
Participants with high carcinoembryonic antigen-related cell adhesion molecule (CEACAM5) expression as per central assessment on tumor biospsy
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of treatment administration
Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration
Signed informed consent

Exclusion Criteria:

Untreated brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
Significant concomitant illness
History within the last 3 years of an invasive malignancy other than that treated in this study
Known uncontrolled infection
Nonresolution of any prior treatment-related toxicity
Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy
Use of contact lenses
Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism
Major surgery within 28 days prior to Day 1/first IMP infusion; subcutaneous venous access device placement within 7 days prior to Day 1; or postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
History of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months before the first treatment administration
Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before the first administration of treatment administration
Uncontrolled arterial hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg) despite standard medical management.
Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of treatment administration
Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of treatment administration
Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention.
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
Concurrent treatment with any other anticancer therapy
Prior treatment targeting CEACAM5 or containing maytansinoid DM1 or DM4 or ramucirumab or taxane or targeting VEGF/VEGFR Poor organ function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number : 0560002		Brussels		BE-1200	Belgium
Investigational Site Number : 0560003

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 milligram/kilogram (mg/kg) via intravenous (IV) infusion followed by tusamitamab ravtansine loading dose at 170 mg/meter square (m^2) via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 and every 2 weeks (Q2W) in all subsequent cycles until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 19, 2021	Jun 19, 2024

ID	Title	Description
BG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants	BG00035

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

Part 1: Number of Participants With Study-Drug Related Dose Limiting Toxicities (DLTs)

The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs:

Grade 4 neutropenia for 7 or more consecutive days.
Grade 3 to 4 neutropenia complicated by fever (temperature >=38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection.
Grade >=3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention.
Grade 4 non-hematologic AE.
Grade >=3 keratopathy. In addition, any other AE that the Investigators and sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT.

DLT-evaluable population included all enrolled participants who received 2 cycles with at least 80% of the intended dose for both tusamitamab ravtansine and ramucirumab at each of the 2 first infusions.

Posted

Count of Participants

Participants

From Cycle 1 Day 1 to Cycle 2 Day 14; approximately 28 days

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants	OG0006

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

Objective Response Rate (ORR)

The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

Posted

Number

95% Confidence Interval

percentage of participants

Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants

Secondary

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

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period.

All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

Posted

Count of Participants

Participants

From the first study drug administration (Day 1) up to 30 days after the last study drug administration, approximately 120 weeks

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Secondary

Duration of Response (DOR)

The DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occured first. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only participants with confirmed CR or PR as BOR were included in the analysis.

Posted

Median

95% Confidence Interval

months

Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants

Secondary

Progression-free Survival (PFS)

The PFS was defined as the time from the first study drug administration to the date of the first documented disease progression or death due to any cause, whichever came first as per RECIST v1.1.

All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

Posted

Median

95% Confidence Interval

months

Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants	OG000

Secondary

Disease Control Rate (DCR)

The DCR was defined as the percentage of participants who achieved confirmed CR, confirmed PR or stable disease (SD) as per RECIST v1.1. The SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered.

Posted

Number

95% Confidence Interval

percentage of participants

Tumor assessments performed at Baseline (Day 1), then every 6 weeks (±7 days) thereafter, approximately 88.1 weeks

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants

Secondary

Individual Observed Predose Concentrations (Ctrough) of Tusamitamab Ravtansine

Blood samples were collected for the measurement of Ctrough of tusamitamab ravtansine.

The Pharmacokinetic (PK) population included all participants from the all-treated population with at least 1 post-baseline PK concentration (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoint are reported.

Posted

Mean

Standard Deviation

microgram/milliliter (mcg/mL)

Pre-infusion on Cycle 2 Day 1

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants

Secondary

Individual Observed Predose Concentrations (Ctrough) of Ramucirumab

Blood samples were collected for the measurement of Ctrough of concentrations of ramucirumab.

The PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration (whatever the cycle and even if dosing was incomplete) with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at specified timepoint are reported.

Posted

Mean

Standard Deviation

mcg/mL

Pre-infusion on Cycle 2 Day 1

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Antitherapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine

Blood samples were collected to assess the presence of ATA against tusamitamab ravtansine in plasma from all participants. ATA incidence was defined as the number of participants found to have seroconverted (treatment-induced ATAs) or boosted their pre-existing ATA response (treatment-boosted ATAs) at any time after first study drug administration.

The ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive).

Posted

Count of Participants

Participants

Upto 92.1 weeks

ID	Title	Description
OG000	Tusamitamab Ravtansine + Ramucirumab	Participants received ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine loading dose at 170 mg/m^2 via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 Q2W in all subsequent cycles until disease progression, unacceptable AE, death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Covid-19	Infections and infestations	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Pneumonia	Infections and infestations	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Pyelonephritis	Infections and infestations	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Malignant Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Tumour Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Anaemia	Blood and lymphatic system disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Syncope	Nervous system disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Abdominal Pain	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Dysphagia	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Haematochezia	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Nausea	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Hydronephrosis	Renal and urinary disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Death	General disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Pyrexia	General disorders	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Alanine Aminotransferase Increased	Investigations	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk
Aspartate Aminotransferase Increased	Investigations	MedDra 27.1	Systematic Assessment	EG0001 events1 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Covid-19	Infections and infestations	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Gastroenteritis	Infections and infestations	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Anaemia	Blood and lymphatic system disorders	MedDra 27.1	Systematic Assessment	EG0007 events6 affected35 at risk
Neutropenia	Blood and lymphatic system disorders	MedDra 27.1	Systematic Assessment	EG00012 events5 affected35 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDra 27.1	Systematic Assessment	EG00011 events5 affected35 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDra 27.1	Systematic Assessment	EG0008 events8 affected35 at risk
Dysgeusia	Nervous system disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Headache	Nervous system disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Keratitis	Eye disorders	MedDra 27.1	Systematic Assessment	EG0004 events3 affected35 at risk
Keratopathy	Eye disorders	MedDra 27.1	Systematic Assessment	EG00013 events8 affected35 at risk
Vision Blurred	Eye disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Hypertension	Vascular disorders	MedDra 27.1	Systematic Assessment	EG00015 events10 affected35 at risk
Hypotension	Vascular disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Ascites	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Constipation	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0004 events4 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG00012 events10 affected35 at risk
Nausea	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0008 events7 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDra 27.1	Systematic Assessment	EG0004 events4 affected35 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDra 27.1	Systematic Assessment	EG0003 events3 affected35 at risk
Proteinuria	Renal and urinary disorders	MedDra 27.1	Systematic Assessment	EG0009 events5 affected35 at risk
Asthenia	General disorders	MedDra 27.1	Systematic Assessment	EG0005 events5 affected35 at risk
Fatigue	General disorders	MedDra 27.1	Systematic Assessment	EG0009 events8 affected35 at risk
Oedema Peripheral	General disorders	MedDra 27.1	Systematic Assessment	EG0002 events2 affected35 at risk
Pyrexia	General disorders	MedDra 27.1	Systematic Assessment	EG0007 events4 affected35 at risk
Alanine Aminotransferase Increased	Investigations	MedDra 27.1	Systematic Assessment	EG0006 events4 affected35 at risk
Aspartate Aminotransferase Increased	Investigations	MedDra 27.1	Systematic Assessment	EG0008 events6 affected35 at risk
Neutrophil Count Decreased	Investigations	MedDra 27.1	Systematic Assessment	EG0008 events3 affected35 at risk
Platelet Count Decreased	Investigations	MedDra 27.1	Systematic Assessment	EG0009 events5 affected35 at risk

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins