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Clinical Trial Results:
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936-0901 (Anti-ADAM9 Antibody Drug Conjugate) in Patients with Advanced Solid Tumors

Summary
EudraCT number	2021-002264-41
Trial protocol	ES
Global end of trial date	28 Dec 2023

Results information
Results version number	v1(current)
This version publication date	05 Jan 2025
First version publication date	05 Jan 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

IMGC936-0901

ISRCTN number

US NCT number

NCT04622774

WHO universal trial number (UTN)

Other trial identifiers

IND Number: 141340

Sponsor organisation name

ImmunoGen, Inc.

Sponsor organisation address

830 Winter Street, Waltham, United States, 02451

Public contact

Kenneth Dhimitri, ImmunoGen, Inc., 001 781207-5341, regulatory.affairs@immunogen.com

Scientific contact

Kenneth Dhimitri, ImmunoGen, Inc., 001 781207-5341, regulatory.affairs@immunogen.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

28 Dec 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Dec 2023

Global end of trial reached?

Yes

Global end of trial date

28 Dec 2023

Was the trial ended prematurely?

Main objective of the trial

Dose Expansion Phase: To describe objective response rate (ORR) for IMGC936 using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Protection of trial subjects

The investigational study was conducted according to the Protection of Human Patients (21 CFR [Code of Federal Regulations] 50), Institutional Review Boards (21 CFR 56), Obligations of Clinical Investigators (21 CFR 312.60–312.69), current ICH guideline for GCP (ICH E6), and all other applicable regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Jan 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 44

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

Spain: 6

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

The study included a Dose Escalation Phase and Dose Expansion Phase.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Dose Escalation - Schedule A: IMGC936 0.5 mg/kg

Arm description

Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule A: IMGC936 1.0 mg/kg

Arm description

Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule A: IMGC936 2.0 mg/kg

Arm description

Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule A: IMGC936 4.0 mg/kg

Arm description

Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule A: IMGC936 5.0 mg/kg

Arm description

Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule A: IMGC936 6.0 mg/kg

Arm description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule A: IMGC936 7.0 mg/kg

Arm description

Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Escalation - Schedule B: IMGC936 2.0 mg/kg

Arm description

Participants received IMGC936 2.0 mg/kg on Days 1, 8, and 15 of a 28-day cycle for the first 2 cycles. On all subsequent cycles (Cycle 3 and beyond), participants received IMGC936 3.0 mg/kg on Days 1 and 8 of a 28-day cycle.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Expansion - NSCLC: IMGC936 6.0 mg/kg

Arm description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Dose Expansion - TNBC: IMGC936 6.0 mg/kg

Arm description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Arm type

Experimental

Investigational medicinal product name

IMGC936

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received IMGC936 as described in arm descriptions.

Number of subjects in period 1	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Started	3	3	3	3	3	10	9	3	13	6
Received at least 1 dose of study drug	3	3	3	3	3	10	9	3	13	6
Completed	3	3	3	3	3	10	9	3	13	6

Baseline characteristics

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Reporting group title

Dose Escalation - Schedule A: IMGC936 0.5 mg/kg

Reporting group description

Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 1.0 mg/kg

Reporting group description

Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter

Reporting group title

Dose Escalation - Schedule A: IMGC936 2.0 mg/kg

Reporting group description

Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 4.0 mg/kg

Reporting group description

Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 5.0 mg/kg

Reporting group description

Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 7.0 mg/kg

Reporting group description

Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule B: IMGC936 2.0 mg/kg

Reporting group description

Reporting group title

Dose Expansion - NSCLC: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Expansion - TNBC: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg	Total
Number of subjects	3	3	3	3	3	10	9	3	13	6	56
Age categorical
Units: Subjects
In utero											0
Preterm newborn infants (gestational age < 37 wks)											0
Newborns (0-27 days)											0
Infants and toddlers (28 days-23 months)											0
Children (2-11 years)											0
Adolescents (12-17 years)											0
Adults (18-64 years)											0
From 65-84 years											0
85 years and over											0
Age continuous
Safety population included all participants who received at least 1 dose of study drug.
Units: years
arithmetic mean (standard deviation)	54.7 ( 5.51 )	53.3 ( 8.39 )	59.3 ( 4.93 )	67.7 ( 5.69 )	61.3 ( 9.81 )	60.4 ( 7.63 )	63.4 ( 8.46 )	61.0 ( 5.57 )	64.8 ( 8.80 )	55.8 ( 10.96 )	-
Gender categorical
Units: Subjects
Female	2	2	3	2	3	3	3	2	6	6	32
Male	1	1	0	1	0	7	6	1	7	0	24
Race
Units: Subjects
Asian	0	1	0	0	0	0	0	0	0	1	2
Black of African American	0	0	0	1	0	0	0	0	1	0	2
White	3	2	2	2	3	9	9	3	11	5	49
Unknown or Not Reported	0	0	1	0	0	1	0	0	1	0	3

End points

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Reporting group title

Dose Escalation - Schedule A: IMGC936 0.5 mg/kg

Reporting group description

Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 1.0 mg/kg

Reporting group description

Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter

Reporting group title

Dose Escalation - Schedule A: IMGC936 2.0 mg/kg

Reporting group description

Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 4.0 mg/kg

Reporting group description

Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 5.0 mg/kg

Reporting group description

Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 7.0 mg/kg

Reporting group description

Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule B: IMGC936 2.0 mg/kg

Reporting group description

Reporting group title

Dose Expansion - NSCLC: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Expansion - TNBC: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Subject analysis set title

Dose Escalation and Dose Expansion: IMGC936 6.0 mg/kg

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Primary: Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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End point title

Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) ^[1] ^[2]

End point description

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AEs with onset date between the first dose of IMGC936 and date of the last dose of IMGC936 + 30 days (inclusive) or date of the first anti-cancer therapy, whichever was earlier. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety population included all participants who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Up to approximately 3 years

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only summary statistics were planned for this endpoint
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg
Number of subjects analysed	3	3	3	3	3	10	9	3
Units: participants
Any TEAEs	3	3	3	3	3	10	9	3
SAEs	1	0	1	0	1	1	4	2

No statistical analyses for this end point

Primary: Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)

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End point title

Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0) ^[3] ^[4]

End point description

DLTs were defined based on TEAEs or abnormal laboratory values that met DLT criteria. Hematologic DLT: Grade 4 neutropenia lasting >7 days; ≥Grade 3 febrile neutropenia Grade 4 thrombocytopenia; Grade 3 thrombocytopenia associated with bleeding; ≥Grade 3 hemolysis. Non-hematologic DLT: Any ≥Grade 3 non-hematologic event, including Grade 3 ocular symptoms and signs; Grade 2 AEs that were prolonged inordinately; • Hepatic laboratory abnormalities meeting Hy’s law criteria; Eye pain or reduction in visual acuity that did not respond to topical ophthalmic therapy. Hepatic DLT: Any elevation of ≥1 transaminases >8 * upper limit of normal (ULN); Any Grade 3 elevation of ≥1 transaminases >5.0–8.0 * ULN that did not resolve to Grade 2 within 7 days and Grade 1 within 14 days; Grade 3 elevation of total bilirubin >5 * ULN; Any Grade 3 elevation of total bilirubin >3.0–5.0 * ULN that did not resolve to Grade 2 within 7 days and Grade 1 within 14 days; Any event meeting criteria for Hy’s law.

End point type

Primary

End point timeframe

Cycle 1 (21 days for Schedule A and 28 days for Schedule B)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only summary statistics were planned for this endpoint
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg
Number of subjects analysed	3	3	3	3	3	10	9	3
Units: participants	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

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End point title

Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) ^[5] ^[6]

End point description

ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD. Response evaluable population included all participants who received at least 1 dose of study drug, had baseline measurable or non-measurable disease, and had at least 1 post-baseline radiographic tumor assessment or discontinued study drug due to clinical progression or death if no post-baseline tumor assessment.

End point type

Primary

End point timeframe

Up to approximately 3 years

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only summary statistics were planned for this endpoint
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Number of subjects analysed	13	6
Units: Percentage of Participants
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)

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End point title

Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax) ^[7]

End point description

The Pharmacokinetics Analysis Set (PAS) included all participants who received at least one dose of IMGC936 and from whom results of plasma or serum concentrations were obtained for at least one sampling point. "99999" = Not calculable due to insufficient number of valid PK parameters.

End point type

Secondary

End point timeframe

Schedule A: Cycle 1 Day 1 (C1D1), C3D1; Schedule B: C1D1, C1D15

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Escalation and Dose Expansion: IMGC936 6.0 mg/kg
Number of subjects analysed	3	3	3	3	3	9	3	29
Units: micrograms/milliliter (μg/mL)
geometric mean (geometric coefficient of variation)
C1D1	14.17 ( 22 )	22.21 ( 5.6 )	56.69 ( 14.2 )	107.2 ( 9.6 )	114.8 ( 30.7 )	162.4 ( 23.7 )	51.74 ( 9.8 )	149.5 ( 21.6 )
C1D15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	168.4 ( 16.4 )

No statistical analyses for this end point

Secondary: Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)

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End point title

Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)

End point description

Safety population included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

Up to approximately 3 years

End point values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Number of subjects analysed	3	3	3	3	3	10	9	3	13	6
Units: participants	3	1	1	0	1	2	0	1	3	1

No statistical analyses for this end point

Secondary: Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1

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End point title

Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1 ^[8]

End point description

ORR was defined as percentage of participants with a confirmed BOR of CR or PR. CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least 30% decrease in the SoD of target lesions, taking as reference the baseline SoD. Response evaluable population included all participants who received at least 1 dose of study drug, had baseline measurable or non-measurable disease, and had at least 1 post-baseline radiographic tumor assessment or discontinued study drug due to clinical progression or death if no post-baseline tumor assessment.

End point type

Secondary

End point timeframe

Up to approximately 3 years

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg
Number of subjects analysed	3	3	3	3	3	10	9	3
Units: percentage of participants
number (confidence interval 95%)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

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End point title

Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

End point description

DOR was defined as the time from the date of the first response (CR or PR), until the date of progressive disease (PD) or death from any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was estimated using the Kaplan-Meier method. "99999" = No participant had response; hence, data could not be calculated.

End point type

Secondary

End point timeframe

Up to approximately 3 years

End point values	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Number of subjects analysed	3	3	3	3	3	10	9	3	13	6
Units: months
median (full range (min-max))	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation

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End point title

Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation ^[9]

End point description

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AEs with onset date between the first dose of IMGC936 and date of the last dose of IMGC936 + 30 days (inclusive) or date of the first anti-cancer therapy, whichever was earlier. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety population included all participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

Up to approximately 3 years

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Number of subjects analysed	13	6
Units: participants
Any TEAEs	13	6
SAEs	4	2
IMGC936 related TEAEs That Led to Discontinuation	1	1

No statistical analyses for this end point

Secondary: Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

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End point title

Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 ^[10]

End point description

PFS was defined as the time from initiation of study drug until the date of PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Response evaluable population included all participants who received at least 1 dose of study drug, had baseline measurable or non-measurable disease, and had at least 1 post-baseline radiographic tumor assessment or discontinued study drug due to clinical progression or death if no post-baseline tumor assessment.

End point type

Secondary

End point timeframe

Up to approximately 3 years

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only summary statistics were planned for this endpoint

End point values	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Number of subjects analysed	13	6
Units: months
median (full range (min-max))	2.7 (0.7 to 6.7)	1.2 (0.0 to 2.4)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to approximately 3 years

Adverse event reporting additional description

Safety population included all participants who received at least 1 dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Dose Escalation - Schedule A: IMGC936 4.0 mg/kg

Reporting group description

Participants received IMGC936 4.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 2.0 mg/kg

Reporting group description

Participants received IMGC936 2.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 1.0 mg/kg

Reporting group description

Participants received IMGC936 1.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter

Reporting group title

Dose Escalation - Schedule A: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 5.0 mg/kg

Reporting group description

Participants received IMGC936 5.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule A: IMGC936 0.5 mg/kg

Reporting group description

Participants received IMGC936 0.5 milligrams (mg)/kilogram (kg) via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Expansion - NSCLC: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Escalation - Schedule B: IMGC936 2.0 mg/kg

Reporting group description

Reporting group title

Dose Escalation - Schedule A: IMGC936 7.0 mg/kg

Reporting group description

Participants received IMGC936 7.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Reporting group title

Dose Expansion - TNBC: IMGC936 6.0 mg/kg

Reporting group description

Participants received IMGC936 6.0 mg/kg via IV infusion on Day 1 of Cycle 1 and every subsequent 21-day cycle thereafter.

Serious adverse events	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	4 / 13 (30.77%)	2 / 3 (66.67%)	4 / 9 (44.44%)	2 / 6 (33.33%)
number of deaths (all causes)	0	1	1	1	1	0	3	1	2	1
number of deaths resulting from adverse events
Investigations
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Hip fracture
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Pericardial effusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Headache
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stenosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bacteraemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mycotic endophthalmitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Dose Escalation - Schedule A: IMGC936 4.0 mg/kg	Dose Escalation - Schedule A: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 1.0 mg/kg	Dose Escalation - Schedule A: IMGC936 6.0 mg/kg	Dose Escalation - Schedule A: IMGC936 5.0 mg/kg	Dose Escalation - Schedule A: IMGC936 0.5 mg/kg	Dose Expansion - NSCLC: IMGC936 6.0 mg/kg	Dose Escalation - Schedule B: IMGC936 2.0 mg/kg	Dose Escalation - Schedule A: IMGC936 7.0 mg/kg	Dose Expansion - TNBC: IMGC936 6.0 mg/kg
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 3 (100.00%)	3 / 3 (100.00%)	3 / 3 (100.00%)	10 / 10 (100.00%)	3 / 3 (100.00%)	3 / 3 (100.00%)	13 / 13 (100.00%)	3 / 3 (100.00%)	9 / 9 (100.00%)	6 / 6 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	0	0	1	0	0	1	2	1	1
Hypotension
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	1	0	1	1	0	0
Embolism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 3 (66.67%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	1 / 3 (33.33%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	1	2	1	0	0	2	1	1	2
Pyrexia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 10 (30.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	3	0	0	1	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1	0	1	0	0	1	0	0	1
Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Chills
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	1	0
Asthenia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0
Chest discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Infusion site extravasation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Sensation of blood flow
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	2	0	1
Hypersensitivity
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0
Reproductive system and breast disorders
Pelvic pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Breast pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	1	0	2	0	0	1
Cough
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	2 / 3 (66.67%)	4 / 13 (30.77%)	1 / 3 (33.33%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	1	1	2	5	1	0	1
Pneumonitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0	0
Hypoxia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	2	0	1	0
Dyspnoea
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	4 / 13 (30.77%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	1	1	5	1	0	0
Pulmonary embolism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0
Wheezing
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Atelectasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Dysphonia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Dyspnoea exertional
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Emphysema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Pleural thickening
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Pneumothorax
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Productive cough
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Rhinorrhoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Lower respiratory tract congestion
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Psychiatric disorders
Mental status changes
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Depression
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Affective disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Delirium
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Confusional state
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0
Insomnia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0
Sleep disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Investigations
Lipase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	3	1	0	0	0	1	3	0
Alanine aminotransferase increased
subjects affected / exposed	2 / 3 (66.67%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	3	0	1	1	1	0	1	1	2	0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	2 / 9 (22.22%)	2 / 6 (33.33%)
occurrences all number	0	0	0	0	1	0	1	1	2	2
Aspartate aminotransferase increased
subjects affected / exposed	2 / 3 (66.67%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	2 / 9 (22.22%)	1 / 6 (16.67%)
occurrences all number	3	0	1	0	0	0	1	2	4	2
Weight decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	1	0	1	0	2	0
Blood bilirubin increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0
Amylase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	5	0	0	0	2	0	1	0
Blood potassium increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Blood creatinine increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0
Blood chloride decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Blood albumin decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 13 (23.08%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	6	0	0	0
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0
Platelet count decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	1	1
International normalised ratio increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0
Blood sodium decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Blood magnesium decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Blood creatine increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Blood calcium increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Bilirubin conjugated increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Blood urea increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Heart rate increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
C-reactive protein increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Neutrophil count increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Troponin T increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Injury, poisoning and procedural complications
Procedural pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Arthropod bite
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Fall
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Infusion related reaction
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	3 / 13 (23.08%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	3	3	0	0	1
Cardiac disorders
Sinus tachycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	1	0	0	0	1	0	0	1
Nervous system disorders
Neuropathy peripheral
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0
Hypoaesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0
Myoclonus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Taste disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Somnolence
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Dizziness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	1	0
Brain oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Headache
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	2 / 3 (66.67%)	0 / 13 (0.00%)	2 / 3 (66.67%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	1	0	0	1	1	3	0	2	0	1
Restless legs syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0
Blood and lymphatic system disorders
Lymphopenia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 13 (23.08%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	5	0	2	0
Thrombocytopenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	2 / 9 (22.22%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	4	0
Anaemia of malignant disease
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Anaemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	5 / 13 (38.46%)	0 / 3 (0.00%)	3 / 9 (33.33%)	1 / 6 (16.67%)
occurrences all number	1	0	1	0	0	0	11	0	4	4
Splenic vein thrombosis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Eye disorders
Dry eye
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	2 / 3 (66.67%)	0 / 3 (0.00%)	5 / 13 (38.46%)	2 / 3 (66.67%)	3 / 9 (33.33%)	2 / 6 (33.33%)
occurrences all number	0	0	0	4	3	0	11	4	4	2
Vision blurred
subjects affected / exposed	2 / 3 (66.67%)	1 / 3 (33.33%)	1 / 3 (33.33%)	6 / 10 (60.00%)	2 / 3 (66.67%)	0 / 3 (0.00%)	8 / 13 (61.54%)	2 / 3 (66.67%)	7 / 9 (77.78%)	4 / 6 (66.67%)
occurrences all number	2	1	1	9	4	0	18	4	10	4
Keratitis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	2 / 3 (66.67%)	0 / 3 (0.00%)	2 / 13 (15.38%)	1 / 3 (33.33%)	4 / 9 (44.44%)	2 / 6 (33.33%)
occurrences all number	1	0	0	2	2	0	17	2	8	3
Keratopathy
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	4 / 9 (44.44%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	1	0	3	0	4	0
Punctate keratitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 13 (23.08%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	5	1	0	0
Photophobia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 13 (30.77%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	5	0	1	1
Cataract
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	1	0	0	3	0	0	1
Visual impairment
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 13 (23.08%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	4	1	0	0
Eye pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	1 / 3 (33.33%)	2 / 9 (22.22%)	1 / 6 (16.67%)
occurrences all number	0	0	0	1	0	0	1	1	2	1
Vitreous floaters
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0
Asthenopia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Eye irritation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Foreign body sensation in eyes
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Corneal epithelial microcysts
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Cornea verticillata
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Diplopia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Eye pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Lacrimation increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Night blindness
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Periorbital oedema
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Ocular hyperaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Gastrointestinal disorders
Vomiting
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	2 / 13 (15.38%)	1 / 3 (33.33%)	4 / 9 (44.44%)	2 / 6 (33.33%)
occurrences all number	0	0	0	2	1	1	2	1	5	2
Nausea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 10 (30.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	3 / 13 (23.08%)	1 / 3 (33.33%)	2 / 9 (22.22%)	1 / 6 (16.67%)
occurrences all number	0	0	0	3	2	1	4	1	2	1
Diarrhoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 13 (15.38%)	1 / 3 (33.33%)	3 / 9 (33.33%)	1 / 6 (16.67%)
occurrences all number	0	0	0	2	0	1	2	1	3	1
Dry mouth
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	1	0	0	0	0	0	1
Abdominal distension
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	2	0	1	1	0	0	0
Abdominal pain upper
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0
Constipation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	1	1	0	0	1
Dyspepsia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0
Ascites
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	2	0	1	1	0	0	0	2	0
Abdominal pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 13 (7.69%)	0 / 3 (0.00%)	2 / 9 (22.22%)	2 / 6 (33.33%)
occurrences all number	0	1	0	0	2	3	1	0	2	3
Dysphagia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	1	0	1
Gastric haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Abdominal discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Large intestinal obstruction
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Gastric stenosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Oesophageal pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Mesenteric vein thrombosis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	1	0	1
Oesophagitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Steatorrhoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Salivary hypersecretion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Proctalgia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Hepatobiliary disorders
Portal vein thrombosis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0
Cholangitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Skin and subcutaneous tissue disorders
Hyperkeratosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Dry skin
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	1	0	0	0	0	0	0	0	1
Pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	0	1	0	1
Rash
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Milia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Pain of skin
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Hyperhidrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Skin hyperpigmentation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Renal and urinary disorders
Renal colic
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Micturition urgency
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Urinary tract pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0
Hydronephrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Nephrolithiasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Haematuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	1 / 3 (33.33%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	0
Muscle spasms
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0
Joint range of motion decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0
Back pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	2	0	0	0
Arthralgia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	2	0	0	1	0	0	0
Joint swelling
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Mixed connective tissue disease
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Tendonitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Infections and infestations
Pneumonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0
COVID-19
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0
Oral candidiasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	2	0	1	0	0	0
Hordeolum
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Skin infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Metabolism and nutrition disorders
Hyperglycaemia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	3 / 13 (23.08%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	1	2	6	0	0	0
Hyponatraemia
subjects affected / exposed	2 / 3 (66.67%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	2	1	0	0	3	0	0	0	1	2
Hypokalaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 13 (7.69%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	3	0	1	1	0	1	0
Decreased appetite
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	1	0
Hypomagnesaemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	1 / 6 (16.67%)
occurrences all number	1	0	0	0	2	0	0	0	0	3
Hypoalbuminaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 13 (15.38%)	0 / 3 (0.00%)	1 / 9 (11.11%)	1 / 6 (16.67%)
occurrences all number	0	0	0	0	0	0	2	0	2	1
Dehydration
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	2	0
Hypocalcaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Hypernatraemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Hyperkalaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Hyperuricaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	1 / 9 (11.11%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0
Vitamin D deficiency
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 13 (7.69%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0
Hypophosphataemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 13 (0.00%)	0 / 3 (0.00%)	0 / 9 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

05 Aug 2020

Amendment 1

22 Apr 2021

Amendment 2

29 Mar 2022

Amendment 3

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936-0901 (Anti-ADAM9 Antibody Drug Conjugate) in Patients with Advanced Solid Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary: Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary: Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)

Primary: Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)

Primary: Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Primary: Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary: Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)

Secondary: Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)

Secondary: Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)

Secondary: Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)

Secondary: Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation

Secondary: Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation

Secondary: Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936-0901 (Anti-ADAM9 Antibody Drug Conjugate) in Patients with Advanced Solid Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary: Dose Escalation Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary: Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)

Primary: Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for AEs Version 5.0 (CTCAE v5.0)

Primary: Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Primary: Dose Expansion Phase: Objective Response Rate (ORR) - Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary: Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)

Secondary: Dose Escalation and Dose Expansion Phase: Maximum Study Drug Concentration (Cmax)

Secondary: Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)

Secondary: Dose Escalation and Dose Expansion Phase: Number of Participants With Antidrug Antibodies (ADA)

Secondary: Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Escalation Phase: ORR - Percentage of Participants With Objective Response as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Escalation and Dose Expansion Phase: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation

Secondary: Dose Expansion Phase: Number of Participants With TEAEs, SAEs, and IMGC936 Related TEAEs That Led to Discontinuation

Secondary: Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

Secondary: Dose Expansion Phase: Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936-0901 (Anti-ADAM9 Antibody Drug Conjugate) in Patients with Advanced Solid Tumors