A Study of the Intra-Patient Escalation Dosing Regimen Wi... | NCT02570308

Label	Type	Description	Intervention Names
Dose escalation	Experimental	Dose escalation cohorts of the intra-patient escalation regimen.	Drug: IMCgp100
Dose expansion	Experimental	Dose expansion cohort with the recommended phase 2 dose of the intra-patient dose escalation regimen.	Drug: IMCgp100

Name	Type	Description	Arm Group Labels	Other Names
IMCgp100	Drug	Bispecific soluble HLA-A2 restricted gp100-specific T-cell receptor fused to anti-CD3	Dose escalation Dose expansion

Measure	Description	Time Frame
Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1	Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.	Up to 49 months
Objective Response Rate in Phase 2	Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.	Up to 38 months

Measure	Description	Time Frame
Objective Response Rate in Phase 1	ORR is defined as the percentage of participants with measurable disease with at least 1 visit response of CR or PR that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an investigator. The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.	Up to 49 months

Facility	Status	City	State	ZIP	Country	Contacts
University California, San Diego Moores Cancer Center		La Jolla	California	92093	United States
The Angeles Clinic and Research Institute - W LA Office

PubMed Identifier	Type	Citation	Retractions
36229663	Derived	Carvajal RD, Butler MO, Shoushtari AN, Hassel JC, Ikeguchi A, Hernandez-Aya L, Nathan P, Hamid O, Piulats JM, Rioth M, Johnson DB, Luke JJ, Espinosa E, Leyvraz S, Collins L, Goodall HM, Ranade K, Holland C, Abdullah SE, Sacco JJ, Sato T. Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial. Nat Med. 2022 Nov;28(11):2364-2373. doi: 10.1038/s41591-022-02015-7. Epub 2022 Oct 13.

ID	Title	Description
FG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
FG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 26, 2018	Jun 17, 2021

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 a Dose Limiting Toxicity (DLT) in Phase 1

Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.

The Safety Analysis Set (SAS) included all participants who received at least 1 full or partial dose of tebentafusp.

Posted

Count of Participants

Participants

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG003	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Units	Counts
Participants	OG0003 OG0016 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0022 OG003

Primary

Objective Response Rate in Phase 2

Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.

The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 38 months

ID	Title	Description
OG000	Phase 2 Dose Expansion: 68 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Units	Counts
Participants	OG000

Secondary

Objective Response Rate in Phase 1

ORR is defined as the percentage of participants with measurable disease with at least 1 visit response of CR or PR that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an investigator. The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.

The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Units	Counts
Participants	OG000

Secondary

Progression-free Survival

Progression-free survival is defined as the time in months from first dose of study drug until the date of disease progression or death (by any cause in the absence of disease progression) as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Posted

Median

95% Confidence Interval

Months

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 2 Dose Expansion	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).

Units	Counts

Secondary

Disease Control Rate

Disease control rate (DCR) is defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD) recorded at least 24 weeks (± 1 week) after commencement of study drug and prior to any progressive disease (PD) event, as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Posted

Number

95% Confidence Interval

Percentage of participants

24 weeks

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 2 Dose Expansion	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).

Secondary

Duration of Response

Duration of response (DOR) is defined as the time in months from the date of first documented objective response (CR or PR) until the date of documented disease progression or death by any cause in the absence of disease progression as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

The analysis population included all participants who received at least 1 full or partial dose of tebentafusp and who achieved a response. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed.

Posted

Median

95% Confidence Interval

Months

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 2 Dose Expansion	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).

Secondary

Time to Response

Time to response (TTR) is defined as the time in months from the date of first dose of study drug until the date of first documented objective response as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2.

Posted

Mean

Standard Deviation

Months

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 2 Dose Expansion	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).

Units	Counts

Secondary

Overall Survival

Overall survival (OS) is defined as the time in months from the date of first dose of study drug until death due to any cause in general.

Posted

Median

95% Confidence Interval

Months

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 2 Dose Expansion	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).

Units	Counts
Participants

Secondary

Minor Response Rate

Rate of minor response (or better) is defined as the proportion of participants with a confirmed CR, PR, or minor response (MinR) as assessed by RECIST v1.1 by the investigator for Phase 1 or ICR for Phase 2, where MinR is a reduction from baseline in sum of diameters between 10%-29%. The sum of diameters is defined as per RECIST v1.1 as the sum of longest diameters or short axis of target lesions (mm).

Posted

Median

95% Confidence Interval

Percentage of participants

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) doses per cohort administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 2 Dose Expansion	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days).

Secondary

Number of Participants With Treatment Dose Interruptions or Reductions

Tolerability of study treatment was assessed by summarizing the number of participants with dose interruptions or reductions that occurred during the treatment period.

The Safety Analysis Set (SAS) included all participants who received at least 1 full or partial dose of tebentafusp.

Posted

Count of Participants

Participants

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 2: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Secondary

Area Under the Plasma Concentration-Time Curve (AUC) of Tebentafusp

The AUC was determined in in dose escalation cohorts.

All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

Posted

Geometric Mean

Standard Deviation

hr*pg/mL

Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Secondary

Maximum Plasma Concentration (Cmax) of Tebentafusp

The Cmax is determined in dose escalation cohorts.

All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

Posted

Geometric Mean

Standard Deviation

pg/mL

Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Secondary

Time to Maximum Plasma Concentration (Tmax) of Tebentafusp

The Tmax of tebentafusp is determined in dose escalation cohorts.

All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

Posted

Median

Full Range

Hours

Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Secondary

Apparent Terminal Plasma Half-life (t½) of Tebentafusp

The t½ of tebentafusp is reported in dose escalation cohorts.

All participants who received at least 1 full or partial dose of tebentafusp and with detectable serum concentrations are included.

Posted

Median

Full Range

Hours

Cycle 1 Day 1 and Cycle 1 Day 15: predose, end of infusion, and 4 and 8 hours postdose

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Secondary

Percentage of Participants With Anti-IMCgp100 Antibody Formation

Overall antidrug antibody (ADA) is presented as number of ADA-positive participants relative to total number of participants with evaluable ADA results in each cohort

The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp and with evaluable data; two participants were excluded from ADA evaluation due to lack of sampling after dosing.

Posted

Number

Percentage of participants

Up to 49 months

ID	Title	Description
OG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
OG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG0032 events1 affected6 at risk EG00411 events9 affected127 at risk
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Infusion-related reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Multiple organ system dysfunction syndrome	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Sepsis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Anal abscess	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Device related infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Lung infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
General physical condition decreased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Platelet count decreased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Aphasia	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hemorrhage intracranial	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Rash generalized	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Embolism	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Infarction	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected6 at risk EG0021 events1 affected4 at risk EG0032 events2 affected6 at risk EG00421 events17 affected127 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Cardiomegaly	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Palpitations	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected4 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hyperacusis	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Otorrhea	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Parasthesia ear	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Dry eye	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Eye inflammation	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Eyelash hypopigmentation	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Ocular hyperemia	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Periorbital edema	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG00113 events4 affected6 at risk EG0029 events3 affected4 at risk EG003
Vision blurred	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Visual impairment	Eye disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0024 events2 affected4 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0019 events4 affected6 at risk EG0027 events3 affected4 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0014 events3 affected6 at risk EG0025 events2 affected4 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG00113 events2 affected6 at risk EG0027 events3 affected4 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Hemorrhoidal hemorrhage	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0007 events2 affected3 at risk EG00121 events5 affected6 at risk EG00218 events4 affected4 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG00113 events3 affected6 at risk EG0025 events3 affected4 at risk EG003
Asthenia	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Chest pain	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0015 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Chills	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0008 events2 affected3 at risk EG00114 events3 affected6 at risk EG00248 events4 affected4 at risk EG003
Face edema	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0024 events1 affected4 at risk EG003
Facial pain	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0009 events2 affected3 at risk EG00116 events5 affected6 at risk EG0026 events4 affected4 at risk EG003
Feeling hot	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Gait disturbance	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Generalized edema	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Impaired healing	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Influenza like illness	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0017 events2 affected6 at risk EG00221 events2 affected4 at risk EG003
Infusion site hematoma	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Malaise	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0014 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Nodule	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0022 events1 affected4 at risk EG003
Edema peripheral	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0003 events3 affected3 at risk EG0019 events5 affected6 at risk EG00212 events3 affected4 at risk EG003
Peripheral swelling	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pyrexia	General disorders	MedDRA 22.0	Non-systematic Assessment	EG00015 events3 affected3 at risk EG00116 events6 affected6 at risk EG00216 events3 affected4 at risk EG003
Temperature regulation disorder	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0024 events2 affected4 at risk EG003
Hyperbilirubinemia	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events2 affected4 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Diverticulitis	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Fungal skin infection	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Localized infection	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Nail infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Oral herpes	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Otitis media	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Sinusitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Skin infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Tooth infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0013 events1 affected6 at risk EG0022 events1 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Wound infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events2 affected4 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG00111 events3 affected6 at risk EG0025 events1 affected4 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0016 events3 affected6 at risk EG0020 events0 affected4 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events2 affected4 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0023 events2 affected4 at risk EG003
Amylase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0016 events2 affected6 at risk EG0023 events2 affected4 at risk EG003
Blood alklaline phosphatase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0015 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Blood creatinine increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Cardiac murmur	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Lipase increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Weight decreased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0021 events1 affected4 at risk EG003
Pain	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0014 events4 affected6 at risk EG0020 events0 affected4 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected4 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected4 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypermagnesemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0017 events4 affected6 at risk EG0026 events3 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0006 events2 affected3 at risk EG00124 events5 affected6 at risk EG0025 events4 affected4 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0005 events3 affected3 at risk EG0018 events3 affected6 at risk EG0025 events1 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG00119 events4 affected6 at risk EG00210 events3 affected4 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG00110 events2 affected6 at risk EG0022 events2 affected4 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0013 events2 affected6 at risk EG0023 events2 affected4 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0014 events1 affected6 at risk EG0022 events2 affected4 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0021 events1 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0009 events1 affected3 at risk EG0015 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Non-systematic Assessment	EG0003 events1 affected3 at risk EG0014 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Tumor inflammation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Non-systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Headache	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0003 events2 affected3 at risk EG0016 events3 affected6 at risk EG0022 events2 affected4 at risk EG003
Dizziness	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0014 events2 affected6 at risk EG0024 events2 affected4 at risk EG003
Paresthesia	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0014 events1 affected6 at risk EG0023 events2 affected4 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0022 events1 affected4 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0023 events2 affected4 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0023 events3 affected4 at risk EG003
Syncope	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Aphasia	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Ataxia	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events2 affected3 at risk EG0013 events3 affected6 at risk EG0020 events0 affected4 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Depression	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected4 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0003 events1 affected3 at risk EG0018 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected6 at risk EG0024 events2 affected4 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0013 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0004 events1 affected3 at risk EG0016 events2 affected6 at risk EG0024 events2 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected4 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0013 events1 affected6 at risk EG0023 events1 affected4 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0006 events3 affected3 at risk EG00125 events4 affected6 at risk EG00218 events4 affected4 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0015 events4 affected6 at risk EG0023 events2 affected4 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0024 events2 affected4 at risk EG003
Hair color changes	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected6 at risk EG0022 events2 affected4 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG00120 events4 affected6 at risk EG00219 events3 affected4 at risk EG003
Rash generalized	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected6 at risk EG0020 events0 affected4 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0013 events3 affected6 at risk EG0022 events2 affected4 at risk EG003
Generalized erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0013 events3 affected6 at risk EG0024 events2 affected4 at risk EG003
Pruritus generalized	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0023 events3 affected4 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG00111 events3 affected6 at risk EG0020 events0 affected4 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0015 events2 affected6 at risk EG00212 events1 affected4 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0002 events1 affected3 at risk EG0019 events3 affected6 at risk EG00215 events2 affected4 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected6 at risk EG0022 events2 affected4 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0023 events2 affected4 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0022 events1 affected4 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0021 events1 affected4 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Ephelides	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0019 events2 affected6 at risk EG0020 events0 affected4 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Miiaria	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Nail discoloration	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0008 events3 affected3 at risk EG0015 events4 affected6 at risk EG0024 events2 affected4 at risk EG003
Hypertension	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0021 events1 affected4 at risk EG003
Hot flush	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected6 at risk EG0020 events0 affected4 at risk EG003
Flushing	Vascular disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected6 at risk EG0020 events0 affected4 at risk EG003

ID	Term
D000098943	Uveal Melanoma
D008545	Melanoma

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
D014604	Uveal Neoplasms
D005134	Eye Neoplasms
D009371	Neoplasms by Site
D005128	Eye Diseases
D014603	Uveal Diseases
D012878	Skin Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
BG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
BG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
BG003	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
BG004	Phase 2 Dose Expansion: 68 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)
BG005	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	Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 54 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	1	3	2	3	3	3
EG001	Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 64 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	5	6	2	6	6	6
EG002	Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 73 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	4	4	3	4	4	4
EG003	Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	4	6	3	6	6	6
EG004	Phase 2 Dose Expansion: 68 mcg Tebentafusp	Fixed low doses of 20 mcg tebentafusp at Cycle 1 Day 1 (C1D1) and 30 mcg at Cycle 1 Day 8 (C1D8), followed by weekly (QW) 68 mcg dose administered intravenously at Cycle 1 Day 15 (C1D15) and beyond (each cycle is 28 days)	69	127	42	127	127	127