An Open-Label, Dose-Escalation Study of IMC-20D7S In Part... | NCT01137006

NCT01137006

ID	Type	Description	Link
CP22-0901	Other Identifier	ImClone, LLC
I4Z-IE-JDEA	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMC-20D7S (1A-4A Cohorts)	Experimental	Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A.	Biological: IMC-20D7S (Cohort 1A) Biological: IMC-20D7S (Cohort 2A) Biological: IMC-20D7S (Cohort 3A) Biological: IMC-20D7S (Cohort 4A)
IMC-20D7S (1B-3B Cohorts)	Experimental	Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B.	Biological: IMC-20D7S (Cohort 1B) Biological: IMC-20D7S (Cohort 2B) Biological: IMC-20D7S (Cohort 3B)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMC-20D7S (Cohort 1A)	Biological	5 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD) of IMC-20D7S	The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.	Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death	A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.	Baseline through 30 days post last dose (up to 31 weeks)

Secondary Outcomes

Measure	Description	Time Frame
IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)	A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.	Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
Participant is ≥18 years of age
Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
Participant has adequate hematological function, hepatic function, and renal function

Exclusion Criteria:

Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
Participant has elective or planned surgery to be conducted during the trial
Participant has documented and/or symptomatic brain or leptomeningeal metastases
Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
Participant has an uncontrolled undercurrent illness
Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
Participant is pregnant or lactating
Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection

Contacts/Locations Module

Name	Affiliation	Role
E-mail: ClinicalTrials@ ImClone.com	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
ImClone Investigational Site		Boston	Massachusetts	02114	United States
ImClone Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 milligrams per kilogram (mg/kg) IMC-20D7S administered intravenously (i.v.) as an infusion every other week (q2w) on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

IMC-20D7S (1A-4A Cohorts)

Participants who received any amount of IMC-20D7S.

Arm/Group Information

ID	Title	Description
BG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
BG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
BG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
BG003	Cohort 4A (30 mg/kg, q2w)	IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
BG004	Cohort 1B (10 mg/kg, q3w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
BG005	Cohort 2B (20 mg/kg, q3w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
BG006	Cohort 3B (30 mg/kg, q3w)	IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
BG007	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG0028 BG0033 BG0043 BG0054 BG0063 BG00727

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00077.7± 5.50 BG00164.9± 4.92 BG00269.8± 8.37 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0003 BG0013 BG002

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

Maximum Tolerated Dose (MTD) of IMC-20D7S

The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.

Participants who completed Cycle 1 of treatment.

Posted

Number

mg/kg q2w

Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]

ID	Title	Description
OG000	IMC-20D7S	IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Units	Counts
Participants	OG00027

Title

Denominators

Categories

Title	Measurements
	OG00020

Primary

Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death

A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Participants who received any amount of IMC-20D7S .

Posted

Number

participants

Baseline through 30 days post last dose (up to 31 weeks)

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

No participant was analyzed.

Posted

Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

IMC-20D7S PK: Minimal Concentration (Cmin)

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

No participant was analyzed.

Posted

Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

IMC-20D7S PK: Half-life (t½)

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

No participant was analyzed.

Posted

Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

IMC-20D7S PK: Clearance (Cl)

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

No participant was analyzed.

Posted

Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

No participant was analyzed.

Posted

Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

IMC-20D7S PK: Volume of Distribution (Vd) at Steady State

A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

No participant was analyzed.

Posted

Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)

Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.

No participant was analyzed.

Posted

Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

Progression-Free Survival (PFS)

PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.

Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3.

Posted

Number

participants

First dose to disease progression or death (up to 27 weeks)

ID	Title	Description
OG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
OG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
OG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Secondary

Recommend Doses for Phase 2/3 Studies Based on MTD

It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.

No participant was analyzed.

Posted

Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]

ID	Title	Description
OG000	IMC-20D7S	IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1A (5 mg/kg, q2w)	IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.	1	3	3	3
EG001	Cohort 2A (10 mg/kg, q2w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.	1	3	3	3
EG002	Cohort 3A (20 mg/kg, q2w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.	5	8	8	8
EG003	Cohort 4A (30 mg/kg, q2w)	IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.	2	3	3	3
EG004	Cohort 1B (10 mg/kg, q3w)	IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.	0	3	2	3
EG005	Cohort 2B (20 mg/kg, q3w)	IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.	4	4	4	4
EG006	Cohort 3B (30 mg/kg, q3w)	IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.	0	3	3	3

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG0030 events0 affected3 at risk EG0040 events0 affected3 at risk EG0050 events0 affected4 at risk EG0060 events0 affected3 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Disease progression	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected8 at risk EG003
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Syncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG0031 events1 affected3 at risk EG0040 events0 affected3 at risk EG0050 events0 affected4 at risk EG0060 events0 affected3 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Eye pain	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Eye swelling	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Breath odour	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0024 events4 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Catheter site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Chills	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Cyst	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Disease progression	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Fatigue	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0025 events4 affected8 at risk EG003
Feeling cold	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Influenza like illness	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Infusion related reaction	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Otitis externa	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Weight increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected8 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0022 events2 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected8 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Nodule on extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected8 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Peroneal nerve palsy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Penile oedema	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected5 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected1 at risk EG0010 events0 affected2 at risk EG0020 events0 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0022 events2 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected8 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0020 events0 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected8 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected8 at risk EG003
Flushing	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003
Haematoma	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected8 at risk EG003

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases