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Clinical Trial Results:
A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed / Refractory Multiple Myeloma – dreaMM 6

Summary
EudraCT number	2017-004689-93
Trial protocol	GB ES
Global end of trial date

Results information
Results version number	v1(current)
This version publication date	15 Mar 2024
First version publication date	15 Mar 2024
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

207497

ISRCTN number

US NCT number

NCT03544281

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS

Public contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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

Interim

Date of interim/final analysis

05 Jun 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Feb 2023

Global end of trial reached?

Main objective of the trial

Part 1 - To determine safety, tolerability, and to determine the RP2D dose of GSK2857916 administered in combination with either Len/Dex (Arm A) or Bor/Dex (Arm B) in subjects with RRMM. Part 2 - To assess the clinical activity after treatment with the RP2D of GSK2857916 administered in combination with Len/Dex (Treatment A) or Bor/Dex (Treatment B) in subjects with RRMM.

Protection of trial subjects

Background therapy

Evidence for comparator

Actual start date of recruitment

20 Sep 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 79

Country: Number of subjects enrolled

Spain: 15

Country: Number of subjects enrolled

United Kingdom: 29

Country: Number of subjects enrolled

United States: 29

Country: Number of subjects enrolled

Canada: 1

Worldwide total number of subjects

153

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

Safety data collection is still ongoing and additional results will be provided after study completion.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Arm description

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin intravenous (IV) solution as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with 25 mg or 10 mg Lenalidomide capsule orally on Days 1-21 of each 28 day cycle with 40 mg Dexamethasone tablet weekly per oral (PO)/ Dexamethasone Sodium Phosphate Injection (USP) as IV on Days 1, 8, 15, & 22 of each cycle

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Arm description

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, Injection, Infusion

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Arm description

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Arm description

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Intravenous use, Oral use, Subcutaneous use

Dosage and administration details

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Arm description

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion, Capsule, Injection

Routes of administration

Oral use, Subcutaneous use, Intravenous use

Dosage and administration details

Number of subjects in period 1 ^[1]	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Started	12	4	13	16	12	12	12	12	13	18	12	16
Completed	0	0	0	0	0	0	0	0	0	0	0	0
Not completed	12	4	13	16	12	12	12	12	13	18	12	16
Adverse event, serious fatal	3	2	6	8	4	2	4	5	5	8	6	4
Consent withdrawn by subject	2	-	1	2	-	-	-	-	2	3	-	4
Physician decision	-	-	-	-	-	-	-	1	-	-	-	-
Ongoing	7	2	6	6	8	10	8	6	6	6	5	8
Investigator Site Closed	-	-	-	-	-	-	-	-	-	1	-	-
Lost to follow-up	-	-	-	-	-	-	-	-	-	-	1	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Worldwide 153 participants were enrolled, whereas 152 participants were actually received the study treatment

Baseline characteristics

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Reporting group title

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex	Total
Number of subjects	12	4	13	16	12	12	12	12	13	18	12	16	152
Age Categorical
Units: Participants
18 to <65 years	4	3	4	4	6	3	4	4	5	6	6	9	58
65 to <75 years	5	1	8	8	3	8	7	4	5	8	5	5	67
>=75 years	3	0	1	4	3	1	1	4	3	4	1	2	27
Sex: Female, Male
Units: Participants
Male	10	4	8	13	7	9	7	5	11	11	8	11	104
Female	2	0	5	3	5	3	5	7	2	7	4	5	48
Race/Ethnicity, Customized
Units: Subjects
African American/African Heritage	0	0	0	1	0	0	1	3	0	4	0	1	10
Asian - Central/South Asian Heritage	0	0	0	1	0	0	0	0	0	1	0	0	2
Asian - East Asian Heritage	0	0	0	0	0	0	0	1	0	0	0	0	1
Asian - South East Asian Heritage	0	0	0	0	1	0	0	0	0	1	0	0	2
Native Hawaiian or Other Pacific Islander	1	0	0	0	0	0	0	0	1	0	0	0	2
White - Arabic/North African Heritage	0	0	0	1	0	0	0	1	0	0	1	0	3
White - White/Caucasian/European Heritage	11	4	13	13	11	11	10	7	11	12	11	15	129
Missing	0	0	0	0	0	1	1	0	1	0	0	0	3

End points

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Reporting group title

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Reporting group description

Primary: Number of participants with DLTs, Treatment B - DLT-evaluable population

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End point title

Number of participants with DLTs, Treatment B - DLT-evaluable population ^[1] ^[2]

End point description

DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting >48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia <25,000/mm^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist >48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment). DLT-evaluable population included participants who received at least 1 full dose of belantamab mafodotin and ≥75% of planned doses of Bor/Dex by the end of Cycle 1 (Day 21).

End point type

Primary

End point timeframe

Up to 21 days

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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.
[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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	6	7
Units: Participants	0	0

No statistical analyses for this end point

Primary: Number of participants with dose limiting toxicities (DLTs), Treatment A - DLT-evaluable population

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End point title

Number of participants with dose limiting toxicities (DLTs), Treatment A - DLT-evaluable population ^[3] ^[4]

End point description

DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting >48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia <25,000/mm^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist >48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment). DLT-evaluable population included participants who received at least 1 full dose of belantamab mafodotin and at least 75% of planned doses of Len/Dex by the end of Cycle 1 (Day 28).

End point type

Primary

End point timeframe

Up to 28 days

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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.
[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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	3	4	6
Units: Participants	0	0	0

No statistical analyses for this end point

Primary: Number of participants with adverse events (AEs) and serious adverse events (SAEs) - All treated population

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End point title

Number of participants with adverse events (AEs) and serious adverse events (SAEs) - All treated population ^[5]

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. All treated population included participants who took at least 1 dose of any study treatment.

End point type

Primary

End point timeframe

Up to approximately 4.5 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Any AE	12	4	13	16	12	12	12	12	13	18	12	16
Any SAE	6	2	6	10	8	8	6	6	7	13	6	9

No statistical analyses for this end point

Primary: Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) - All treated population

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End point title

Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) - All treated population ^[6]

End point description

12-lead electrocardiogram (ECGs) were obtained using an automated electrocardiogram (ECG) machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and >60 msec, and >530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data of number of participants with worst-case increase post baseline is presented.

End point type

Primary

End point timeframe

Up to approximately 4.5 years

Notes
[6] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	10	12	12	12	13	18	12	16
Units: Participants
Increase of 31-60 msec	3	3	5	3	1	3	1	2	5	4	5	5
Increase of >60 msec	0	0	3	2	0	0	0	0	1	2	0	0
Increase of >530 msec	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters - All treated population

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End point title

Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters - All treated population ^[7]

End point description

Blood samples were collected for analysis of following hematology parameters: Hemoglobin (hemoglobin increased and anemia), Lymphocytes (lymphocyte count increased and lymphocyte count decreased), Neutrophils, Platelets and Leukocytes (leukocytosis and white blood cells decreased). The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[7] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Hemoglobin increased, Any Grade Increase	0	0	0	0	0	0	1	0	0	1	0	1
Hemoglobin increased, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Hemoglobin increased, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Anemia, Any Grade Increase	7	2	8	9	5	6	2	3	9	11	8	10
Anemia, Increase to Grade 3	0	0	3	2	2	2	1	2	5	2	2	3
Anemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Lymphocyte count increased, Any Grade Increase	0	1	0	0	2	2	0	0	0	0	0	1
Lymphocyte count increased, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Lymphocyte count increased, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Lymphocyte count decreased, Any Grade Increase	11	3	10	12	11	12	10	11	12	13	10	15
Lymphocyte count decreased, Increase to Grade 3	7	1	3	4	5	6	3	5	6	6	3	8
Lymphocyte count decreased, Increase to Grade 4	0	0	1	3	1	3	2	1	3	2	3	1
Neutrophils, Any Grade Increase	8	3	9	9	6	6	5	4	7	10	8	9
Neutrophils, Increase to Grade 3	3	2	4	4	1	3	3	1	3	1	4	2
Neutrophils, Increase to Grade 4	0	0	1	1	0	1	0	0	1	3	0	0
Platelets, Any Grade Increase	9	4	12	15	11	12	11	12	13	18	12	16
Platelets, Increase to Grade 3	1	1	4	5	3	2	4	3	5	3	2	3
Platelets, Increase to Grade 4	1	0	2	1	7	9	5	6	6	9	9	10
Leukocytosis, Any Grade Increase	0	0	0	0	0	0	0	0	0	0	0	0
Leukocytosis, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Leukocytosis, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
White blood cell decreased, Any Grade Increase	10	3	11	8	5	8	3	7	8	11	8	13
White blood cell decreased, Increase to Grade 3	2	0	1	3	1	2	1	0	2	3	3	0
White blood cell decreased, Increase to Grade 4	0	0	0	2	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters - All treated population

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End point title

Number of Participants With Worst-case Change Post-baseline in Hematology Parameters - All treated population ^[8]

End point description

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, erythrocytes and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[8] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Basophils, Decrease to Low	0	0	0	0	1	1	0	0	0	1	0	2
Basophils, Change to Normal or No Change	10	4	10	10	9	10	10	11	11	12	11	12
Basophils, Increase to High	2	0	3	4	2	1	2	1	2	2	1	1
Eosinophils, Decrease to Low	2	1	4	2	1	3	0	2	3	2	1	2
Eosinophils, Change to Normal or No Change	7	2	8	7	11	9	12	10	10	11	10	13
Eosinophils, Increase to High	3	2	3	6	0	0	0	1	0	3	1	0
Hematocrit, Decrease to Low	4	1	1	4	2	5	1	1	3	3	1	7
Hematocrit, Change to Normal or No Change	8	3	12	12	10	7	9	11	10	14	11	8
Hematocrit, Increase to High	1	0	0	0	0	1	2	0	0	1	0	1
MCH, Decrease to Low	0	0	3	1	0	3	1	3	2	6	2	1
MCH, Change to Normal or No Change	9	3	7	13	10	7	8	9	10	9	10	11
MCH, Increase to High	3	1	3	2	2	3	3	0	1	4	0	4
MCHC, Decrease to Low	4	0	4	4	2	6	5	6	6	7	5	5
MCHC, Change to Normal or No Change	8	3	9	12	8	6	6	6	6	10	6	11
MCHC, Increase to High	0	1	1	0	2	1	1	0	1	2	1	0
MCV, Decrease to Low	0	0	4	1	0	2	1	2	0	4	0	0
MCV, Change to Normal or No Change	10	3	7	11	10	7	7	10	11	10	10	13
MCV, Increase to High	2	1	3	4	2	3	5	1	2	4	2	3
Monocytes, Decrease to Low	5	1	4	3	5	4	7	8	5	7	3	5
Monocytes, Change to Normal or No Change	4	2	2	4	3	1	1	1	2	3	5	4
Monocytes, Increase to High	4	2	11	10	6	10	10	8	8	10	5	8
Erythrocytes, Decrease to Low	2	1	0	1	0	2	0	0	0	4	2	3
Erythrocytes, Change to Normal or No Change	9	3	13	13	11	10	12	11	13	14	9	13
Erythrocytes, Increase to High	1	0	0	2	1	1	0	1	0	0	1	0
Reticulocytes, Decrease to Low	3	1	2	4	1	1	2	4	2	4	3	5
Reticulocytes, Change to Normal or No Change	7	1	5	7	9	6	5	2	8	6	4	2
Reticulocytes, Increase to High	3	2	7	6	2	6	7	8	3	9	6	10

No statistical analyses for this end point

Primary: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters - All treated population

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End point title

Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters - All treated population ^[9]

End point description

Blood samples were collected for analysis of following clinical chemistry parameters: Hyperglycemia, Hypoglycemia, Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase, (AST), Bilirubin, Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Hyperkalemia, Hypokalemia, Hypermagnesemia, Hypomagnesemia, Phosphate, Hypernatremia, Hyponatremia, Urate, Hypercalcemia and Hypocalcemia. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[9] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Hyperglycemia, Any Grade Increase	3	1	9	11	8	9	9	8	5	10	6	8
Hyperglycemia, Increase to Grade 3	0	0	0	1	0	0	3	1	1	1	0	1
Hyperglycemia, Increase to Grade 4	0	0	0	1	0	0	0	0	1	0	0	1
Hypoglycemia, Any Grade Increase	2	0	1	1	0	2	1	3	0	1	0	1
Hypoglycemia, Increase to Grade 3	0	0	0	0	0	0	0	1	0	0	0	0
Hypoglycemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Albumin, Any Grade Increase	6	2	8	9	5	8	4	5	7	14	5	8
Albumin, Increase to Grade 3	0	0	0	0	0	2	0	2	2	0	0	0
Albumin, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Alkaline Phosphatase, Any Grade Increase	4	0	7	6	6	4	5	6	8	8	2	5
Alkaline Phosphatase, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Alkaline Phosphatase, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
ALT, Any Grade Increase	7	1	7	7	5	5	9	8	6	6	7	8
ALT, Increase to Grade 3	0	0	0	0	0	1	2	1	1	0	0	1
ALT, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	1
AST, Any Grade Increase	4	2	8	6	10	12	8	10	8	11	8	12
AST, Increase to Grade 3	0	0	0	0	0	1	1	3	1	0	0	0
AST, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	1
Bilirubin, Any Grade Increase	1	0	1	4	2	2	0	3	2	2	1	5
Bilirubin, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	1
Bilirubin, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
CK, Any Grade Increase	3	2	4	2	1	3	3	4	4	4	4	7
CK, Increase to Grade 3	1	0	0	0	0	0	0	1	1	0	0	0
CK, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Creatinine, Any Grade Increase	1	0	7	2	2	2	6	2	4	3	1	6
Creatinine, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Creatinine, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
GGT, Any Grade Increase	9	1	9	9	6	7	5	10	8	10	6	9
GGT, Increase to Grade 3	2	0	2	4	1	2	1	2	1	2	0	2
GGT, Increase to Grade 4	0	0	0	0	0	0	0	1	0	0	0	0
Hyperkalemia, Any Grade Increase	0	0	1	1	0	2	0	0	3	3	0	3
Hyperkalemia, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Hyperkalemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Hypokalemia, Any Grade Increase	3	2	3	4	6	4	8	3	4	6	7	4
Hypokalemia, Increase to Grade 3	1	0	2	2	0	1	0	0	0	0	0	1
Hypokalemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Hypermagnesemia, Any Grade Increase	0	0	1	0	2	0	1	0	4	1	1	2
Hypermagnesemia, Increase to Grade 3	0	0	0	0	0	0	0	0	1	0	0	1
Hypermagnesemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Hypomagnesemia, Any Grade Increase	3	2	3	4	3	2	0	1	1	7	4	4
Hypomagnesemia, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Hypomagnesemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Phosphate, Any Grade Increase	6	3	5	4	4	7	6	5	8	8	8	7
Phosphate, Increase to Grade 3	2	1	3	1	0	2	2	2	3	3	3	0
Phosphate, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Hypernatremia, Any Grade Increase	1	0	1	1	1	2	4	2	1	1	1	2
Hypernatremia, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Hypernatremia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Hyponatremia, Any Grade Increase	4	1	3	3	4	3	3	5	4	4	2	5
Hyponatremia, Increase to Grade 3	0	1	0	2	1	0	0	2	1	1	0	1
Hyponatremia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	0	0	0
Urate, Any Grade Increase	1	0	1	1	1	1	0	1	0	0	0	1
Urate, Increase to Grade 3	0	0	0	0	0	0	0	0	0	0	0	0
Urate, Increase to Grade 4	1	0	1	1	1	1	0	1	0	0	0	1
Hypercalcemia, Any Grade Increase	0	0	2	1	2	2	2	1	3	4	1	1
Hypercalcemia, Increase to Grade 3	0	0	1	0	0	0	0	0	1	1	0	0
Hypercalcemia, Increase to Grade 4	0	0	0	0	0	0	0	0	0	1	0	0
Hypocalcemia, Any Grade Increase	5	0	4	2	1	3	2	2	5	1	0	3
Hypocalcemia, Increase to Grade 3	1	0	0	0	0	0	0	0	1	0	0	0
Hypocalcemia, Increase to Grade 4	3	0	2	1	0	1	0	1	2	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters - All treated population

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End point title

Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters - All treated population ^[10]

End point description

Blood samples were collected for analysis of following clinical chemistry parameters: Direct Bilirubin (DB), Calcium, Chloride, Carbon Dioxide (CO2), lactate dehydrogenase (LDH) and Protein. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[10] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
DB, Decrease to Low	0	0	0	0	0	0	0	0	0	0	0	0
DB, Change to Normal or No Change	4	4	9	8	11	8	10	9	9	13	10	14
DB, Increase to High	6	0	4	5	1	4	2	2	3	5	2	2
Calcium, Decrease to Low	7	1	7	7	2	6	4	2	5	9	2	5
Calcium, Change to Normal or No Change	5	3	6	7	8	5	6	10	8	8	6	11
Calcium, Increase to High	0	0	1	1	2	1	2	0	1	2	4	1
Chloride, Decrease to Low	1	1	1	3	0	0	1	1	3	3	1	2
Chloride, Change to Normal or No Change	5	3	8	10	8	7	5	10	7	9	10	12
Chloride, Increase to High	5	0	4	2	4	5	6	1	4	6	1	2
CO2, Decrease to Low	5	0	5	5	5	3	3	1	5	4	4	2
CO2, Change to Normal or No Change	7	4	7	7	5	7	9	8	6	14	8	11
CO2, Increase to High	0	0	1	2	1	2	0	3	2	1	0	3
Protein, Decrease to Low	8	2	5	12	3	7	7	6	7	11	7	10
Protein, Change to Normal or No Change	4	2	8	3	8	5	4	5	5	5	4	5
Protein, Increase to High	0	0	0	1	1	0	1	1	1	2	1	1
LDH, Decrease to Low	0	0	2	2	0	0	0	1	1	0	2	0
LDH, Change to Normal or No Change	5	1	3	6	4	4	3	4	4	1	4	5
LDH, Increase to High	6	3	9	8	8	8	9	7	8	17	8	11

No statistical analyses for this end point

Primary: Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein - All treated population

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End point title

Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein - All treated population ^[11]

End point description

Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, >3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[11] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Occult Blood, No Change/Decreased	5	2	6	6	6	8	6	9	4	11	7	12
Occult Blood, Increase to TRACE	1	2	3	4	0	2	2	1	5	1	0	0
Occult Blood, Increase to 1+	1	0	1	0	2	0	1	1	1	4	2	3
Occult Blood, Increase to 2+	3	0	2	2	1	1	2	1	1	1	2	1
Occult Blood, Increase to 3+	0	0	0	1	0	1	1	0	0	1	0	0
Occult Blood, Increase to >3+	0	0	1	0	0	0	0	0	0	0	0	0
Protein, No Change/Decreased	5	2	7	3	2	5	5	6	5	8	4	5
Protein, Increase to TRACE	2	0	1	6	1	2	2	2	1	2	0	1
Protein, Increase to 1+	1	0	3	0	2	2	4	2	2	4	2	6
Protein, Increase to 2+	2	0	2	3	2	0	1	2	2	2	2	3
Protein, Increase to 3+	0	2	0	1	1	3	0	0	2	2	3	1
Protein, Increase to >3+	0	0	0	0	1	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Change from baseline in urine Potential of Hydrogen (pH) - All treated population

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End point title

Change from baseline in urine Potential of Hydrogen (pH) - All treated population ^[12]

End point description

Urine samples were collected to analyze urine pH levels. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[12] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	10	4	13	12	12	12	12	12	13	18	12	16
Units: Potential of Hydrogen (pH)
arithmetic mean (standard deviation)
Baseline (Day 1)	5.9 ( 0.46 )	5.8 ( 0.65 )	6.0 ( 0.90 )	5.8 ( 0.69 )	6.1 ( 0.68 )	5.8 ( 0.62 )	6.4 ( 0.87 )	5.6 ( 0.48 )	5.9 ( 0.82 )	6.1 ( 0.82 )	5.9 ( 1.18 )	5.7 ( 0.70 )
End of Treatment	0.1 ( 1.08 )	-0.2 ( 0.76 )	0.4 ( 1.38 )	0.2 ( 0.29 )	-0.3 ( 0.61 )	0.6 ( 0.42 )	-0.5 ( 0.50 )	0.2 ( 0.66 )	0.4 ( 1.03 )	0.2 ( 0.80 )	0.4 ( 0.55 )	0.2 ( 1.05 )

No statistical analyses for this end point

Primary: Change from baseline in urine specific gravity - All treated population

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End point title

Change from baseline in urine specific gravity - All treated population ^[13]

End point description

Urine samples were collected to analyze urine specific gravity using dipstick method. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

Notes
[13] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	7	4	13	11	6	12	9	11	12	18	11	14
Units: Ratio
arithmetic mean (standard deviation)
Baseline (Day 1)	1.0217 ( 0.00687 )	1.0253 ( 0.00660 )	1.0169 ( 0.00946 )	1.0175 ( 0.00682 )	1.0217 ( 0.00931 )	1.0175 ( 0.00544 )	1.0133 ( 0.00661 )	1.0167 ( 0.00736 )	1.0193 ( 0.00612 )	1.0152 ( 0.00817 )	1.0174 ( 0.00713 )	1.0139 ( 0.00627 )
End of Treatment	0.0003 ( 0.00058 )	-0.0090 ( 0.01217 )	-0.0013 ( 0.01072 )	0.0023 ( 0.00643 )	0.0075 ( 0.00354 )	-0.0020 ( 0.00671 )	0.0050 ( 0.00707 )	0.0029 ( 0.01029 )	-0.0010 ( 0.00529 )	0.0005 ( 0.00782 )	-0.0026 ( 0.00792 )	0.0067 ( 0.00830 )

No statistical analyses for this end point

Primary: Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP) - All treated population

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End point title

Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP) - All treated population ^[14]

End point description

Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. 99999 = Data cannot be evaluated for single participant. 88888 = Data was not collected for particular timepoint.

End point type

Primary

End point timeframe

Baseline (Day 1, predose) and up to approximately 4.5 years

Notes
[14] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	17	12	16
Units: Millimeters of mercury (mmHg)
arithmetic mean (standard deviation)
DBP, BASELINE (Day 1)	72.3 ( 7.67 )	86.0 ( 12.49 )	79.5 ( 9.36 )	71.4 ( 12.04 )	73.6 ( 17.15 )	75.1 ( 9.08 )	78.4 ( 11.13 )	76.1 ( 7.14 )	72.2 ( 8.52 )	74.9 ( 8.77 )	72.9 ( 11.85 )	77.8 ( 10.61 )
DBP, WEEK 79 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	19.0 ( 99999 )	2.0 ( 99999 )	-1.0 ( 99999 )	-23.0 ( 99999 )
DBP, WEEK 79 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-8.0 ( 99999 )	-3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	12.0 ( 99999 )	-2.0 ( 99999 )	-11.0 ( 99999 )	-14.0 ( 99999 )
DBP, WEEK 79 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	-6.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	19.0 ( 99999 )	5.0 ( 99999 )	-10.0 ( 99999 )	-44.0 ( 99999 )
DBP, WEEK 91 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	6.0 ( 99999 )	88888 ( 88888 )	4.0 ( 99999 )	-4.0 ( 99999 )	-26.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 91 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.0 ( 0.0 )	88888 ( 88888 )	10.0 ( 99999 )	1.0 ( 99999 )	-15.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 91 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	10.0 ( 99999 )	88888 ( 88888 )	3.0 ( 99999 )	-2.0 ( 99999 )	-16.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 94 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-24.0 ( 99999 )	88888 ( 88888 )	4.0 ( 99999 )	-7.0 ( 99999 )	-2.0 ( 99999 )	88888 ( 88888 )
DBP, WEEK 94 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-21.0 ( 99999 )	88888 ( 88888 )	6.0 ( 99999 )	4.0 ( 99999 )	3.0 ( 99999 )	88888 ( 88888 )
DBP, WEEK 94 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-21.0 ( 99999 )	88888 ( 88888 )	14.0 ( 99999 )	-5.0 ( 99999 )	2.0 ( 99999 )	88888 ( 88888 )
DBP, WEEK 109 DAY 1, Predose	5.0 ( 99999 )	88888 ( 88888 )	2.0 ( 99999 )	-1.7 ( 2.08 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-4.5 ( 0.71 )	6.0 ( 99999 )	88888 ( 88888 )	-14.0 ( 99999 )
DBP, WEEK 109 DAY 1, 0.25hour Post-Dose	-4.0 ( 99999 )	88888 ( 88888 )	-2.0 ( 99999 )	0.0 ( 6.24 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	1.5 ( 7.78 )	6.0 ( 99999 )	88888 ( 88888 )	-21.0 ( 99999 )
DBP, WEEK 109 DAY 1, 1hour Post-Dose	9.0 ( 99999 )	88888 ( 88888 )	2.0 ( 99999 )	0.0 ( 5.57 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	5.5 ( 2.12 )	3.0 ( 99999 )	88888 ( 88888 )	-27.0 ( 99999 )
DBP, WEEK 133 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-2.0 ( 2.83 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	6.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-16.0 ( 99999 )
DBP, WEEK 133 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	1.0 ( 7.07 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-18.0 ( 99999 )
DBP, WEEK 133 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	4.5 ( 3.54 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	8.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-14.0 ( 99999 )
DBP, WEEK 153 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	5.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 153 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	10.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 153 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	4.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 169 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	11.0 ( 99999 )	-16.5 ( 26.16 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 169 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	6.0 ( 99999 )	3.0 ( 4.24 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 169 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	7.0 ( 99999 )	-11.0 ( 16.97 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 169 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	11.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 169 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	6.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 169 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 173 DAY 1, Predose	88888 ( 88888 )	-14.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 173 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	-10.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 173 DAY 1, 1hour Post-Dose	88888 ( 88888 )	-3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 221 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-2.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 221 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-10.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
DBP, WEEK 221 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	2.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, BASELINE (Day 1)	127.8 ( 18.62 )	137.5 ( 7.05 )	136.1 ( 26.03 )	125.3 ( 15.71 )	136.4 ( 18.99 )	129.7 ( 15.13 )	132.8 ( 17.88 )	135.4 ( 16.68 )	122.3 ( 13.94 )	143.3 ( 25.93 )	126.8 ( 21.48 )	138.5 ( 21.29 )
SBP, WEEK 79 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	11.0 ( 99999 )	5.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	8.0 ( 99999 )	16.0 ( 99999 )	-17.0 ( 99999 )	-21.0 ( 99999 )
SBP, WEEK 79 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	10.0 ( 99999 )	-3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	8.0 ( 99999 )	9.0 ( 99999 )	-36.0 ( 99999 )	-7.0 ( 99999 )
SBP, WEEK 79 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	12.0 ( 99999 )	-2.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-1.0 ( 99999 )	0.0 ( 0.0 )	-41.0 ( 99999 )	-1.0 ( 99999 )
SBP, WEEK 91 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	88888 ( 88888 )	-2.0 ( 99999 )	4.0 ( 99999 )	-22.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 91 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-15.0 ( 99999 )	88888 ( 88888 )	17.0 ( 99999 )	12.0 ( 99999 )	-31.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 91 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	21.0 ( 99999 )	88888 ( 88888 )	16.0 ( 99999 )	4.0 ( 99999 )	-15.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 94 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-28.0 ( 99999 )	88888 ( 88888 )	-5.0 ( 99999 )	-38.0 ( 99999 )	12.0 ( 99999 )	88888 ( 88888 )
SBP, WEEK 94 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-30.0 ( 99999 )	88888 ( 88888 )	-4.0 ( 99999 )	-23.0 ( 99999 )	3.0 ( 99999 )	88888 ( 88888 )
SBP, WEEK 94 DAY 1, 1hour Post-Dose	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-35.0 ( 99999 )	99999 ( 99999 )	-4.0 ( 99999 )	-32.0 ( 99999 )	-5.0 ( 99999 )	99999 ( 99999 )
SBP, WEEK 109 DAY 1, Predose	9.0 ( 99999 )	88888 ( 88888 )	-1.0 ( 99999 )	-4.7 ( 16.01 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-1.0 ( 5.66 )	-11.0 ( 99999 )	88888 ( 88888 )	-22.0 ( 99999 )
SBP, WEEK 109 DAY 1, 0.25hour Post-Dose	3.0 ( 99999 )	99999 ( 99999 )	1.0 ( 99999 )	1.3 ( 15.89 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-7.5 ( 0.71 )	0.0 ( 0.0 )	99999 ( 88888 )	-23.0 ( 99999 )
SBP, WEEK 109 DAY 1, 1hour Post-Dose	3.0 ( 99999 )	88888 ( 88888 )	-3.0 ( 99999 )	7.3 ( 16.56 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-1.5 ( 4.95 )	8.0 ( 99999 )	88888 ( 88888 )	-31.0 ( 99999 )
SBP, WEEK 133 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-9.0 ( 1.41 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	4.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-16.0 ( 99999 )
SBP, WEEK 133 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	3.0 ( 9.90 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-2.0 ( 99999 )
SBP, WEEK 133 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	5.0 ( 19.80 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-1.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-1.0 ( 99999 )
SBP, WEEK 153 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	-3.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 153 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	13.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 153 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	7.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 169 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	-16.5 ( 28.99 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 169 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	-9.5 ( 7.78 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 169 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-1.0 ( 99999 )	-6.5 ( 9.19 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 169 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	10.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 169 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	11.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 169 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	17.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 173 DAY 1, Predose	88888 ( 88888 )	-7.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 173 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	-7.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 173 DAY 1, 1hour Post-Dose	88888 ( 88888 )	-5.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 221 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	18.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 221 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	15.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SBP, WEEK 221 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	32.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Primary: Change from Baseline in vital Signs : Pulse Rate - All treated population

Top of page

End point title

Change from Baseline in vital Signs : Pulse Rate - All treated population ^[15]

End point description

Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. 99999 = Data cannot be evaluated for single participant. 88888 = Data was not collected for particular timepoint.

End point type

Primary

End point timeframe

Baseline (Day 1, pre-dose) and up to approximately 4.5 years

Notes
[15] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	17	12	16
Units: beats per minute
arithmetic mean (standard deviation)
BASELINE (Day 1)	72.8 ( 9.01 )	73.8 ( 11.90 )	76.0 ( 17.10 )	72.8 ( 14.65 )	73.7 ( 13.05 )	76.2 ( 12.69 )	75.5 ( 11.21 )	79.6 ( 13.36 )	73.3 ( 14.31 )	74.1 ( 10.76 )	81.0 ( 10.05 )	75.3 ( 10.82 )
WEEK 79 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-9.0 ( 99999 )	-18.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-14.0 ( 99999 )	9.0 ( 99999 )	1.0 ( 99999 )	4.0 ( 99999 )
WEEK 79 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-6.0 ( 99999 )	-6.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	6.0 ( 99999 )	-2.0 ( 99999 )	2.0 ( 99999 )	-9.0 ( 99999 )
WEEK 79 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-18.0 ( 99999 )	6.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	13.0 ( 99999 )	-2.0 ( 99999 )	4.0 ( 99999 )	-6.0 ( 99999 )
WEEK 91 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	1.0 ( 99999 )	88888 ( 88888 )	-5.0 ( 99999 )	24.0 ( 99999 )	-5.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 91 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-2.0 ( 99999 )	88888 ( 88888 )	-19.0 ( 99999 )	12.0 ( 99999 )	-9.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 91 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-6.0 ( 99999 )	88888 ( 88888 )	-11.0 ( 99999 )	11.0 ( 99999 )	-19.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 94 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )	88888 ( 88888 )	-14.0 ( 99999 )	21.0 ( 99999 )	13.0 ( 99999 )	88888 ( 88888 )
WEEK 94 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-4.0 ( 99999 )	88888 ( 88888 )	-22.0 ( 99999 )	16.0 ( 99999 )	12.0 ( 99999 )	88888 ( 88888 )
WEEK 94 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-4.0 ( 99999 )	88888 ( 88888 )	-28.0 ( 99999 )	11.0 ( 99999 )	14.0 ( 99999 )	88888 ( 88888 )
WEEK 109 DAY 1, Predose	-19.0 ( 99999 )	88888 ( 88888 )	-22.0 ( 99999 )	8.3 ( 5.13 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-6.0 ( 8.49 )	-12.0 ( 99999 )	88888 ( 88888 )	-9.0 ( 99999 )
WEEK 109 DAY 1, 0.25hour Post-Dose	-18.0 ( 99999 )	88888 ( 88888 )	-24.0 ( 99999 )	0.3 ( 3.06 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	10.5 ( 41.72 )	-16.0 ( 99999 )	88888 ( 88888 )	-8.0 ( 99999 )
WEEK 109 DAY 1, 1hour Post-Dose	-4.0 ( 99999 )	88888 ( 88888 )	-25.0 ( 99999 )	1.3 ( 5.69 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-8.0 ( 11.31 )	-12.0 ( 99999 )	88888 ( 88888 )	0.0 ( 0.0 )
WEEK 133 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	6.5 ( 9.19 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-11.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )
WEEK 133 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	4.5 ( 0.71 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-12.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-5.0 ( 99999 )
WEEK 133 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	5.5 ( 2.12 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-16.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-17.0 ( 99999 )
WEEK 153 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	-8.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 153 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	-10.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 153 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	-9.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-15.0 ( 99999 )	-21.0 ( 5.66 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-23.0 ( 99999 )	-19.0 ( 2.83 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-20.0 ( 99999 )	-21.0 ( 1.41 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-21.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-17.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-20.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 173 DAY 1, Predose	88888 ( 88888 )	-7.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 173 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	-5.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 173 DAY 1, 1hour Post-Dose	88888 ( 88888 )	-8.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 221 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-4.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 221 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	2.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 221 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	8.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Primary: Change from Baseline in vital Signs : Temperature - All treated population

Top of page

End point title

Change from Baseline in vital Signs : Temperature - All treated population ^[16]

End point description

Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. 99999 = Data cannot be evaluated for single participant. 88888 = Data was not collected for particular timepoint.

End point type

Primary

End point timeframe

Baseline (Day 1, pre-dose) and up to approximately 4.5 years

Notes
[16] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	17	12	16
Units: Degree Celsius (C)
arithmetic mean (standard deviation)
BASELINE (Day 1)	36.61 ( 0.417 )	36.70 ( 0.346 )	36.46 ( 0.307 )	36.43 ( 0.334 )	36.46 ( 0.348 )	36.44 ( 0.291 )	36.52 ( 0.432 )	36.68 ( 0.305 )	36.53 ( 0.338 )	36.48 ( 0.571 )	36.51 ( 0.581 )	36.58 ( 0.397 )
WEEK 79 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.30 ( 99999 )	0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	0.70 ( 99999 )	-0.10 ( 99999 )	1.30 ( 99999 )	0.00 ( 0.00 )
WEEK 79 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.30 ( 99999 )	0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	-0.20 ( 99999 )	-0.10 ( 99999 )	1.60 ( 99999 )	0.00 ( 0.00 )
WEEK 79 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.10 ( 99999 )	0.40 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	0.50 ( 99999 )	0.00 ( 0.00 )	1.40 ( 99999 )	0.00 ( 0.00 )
WEEK 91 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.40 ( 99999 )	88888 ( 88888 )	-0.60 ( 99999 )	0.50 ( 99999 )	-0.70 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 91 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.40 ( 99999 )	88888 ( 88888 )	-0.80 ( 99999 )	0.10 ( 99999 )	0.20 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 91 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.50 ( 99999 )	88888 ( 88888 )	-0.50 ( 99999 )	0.50 ( 99999 )	0.30 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 94 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.20 ( 99999 )	88888 ( 88888 )	0.10 ( 99999 )	-0.30 ( 99999 )	0.30 ( 99999 )	88888 ( 88888 )
WEEK 94 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.30 ( 99999 )	88888 ( 88888 )	0.30 ( 99999 )	0.10 ( 99999 )	0.30 ( 99999 )	88888 ( 88888 )
WEEK 94 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.40 ( 99999 )	88888 ( 88888 )	0.00 ( 0.00 )	0.10 ( 99999 )	0.30 ( 99999 )	88888 ( 88888 )
WEEK 109 DAY 1, Predose	-0.90 ( 99999 )	88888 ( 88888 )	-0.80 ( 99999 )	0.20 ( 0.173 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.20 ( 0.283 )	-0.20 ( 99999 )	88888 ( 88888 )	0.40 ( 99999 )
WEEK 109 DAY 1, 0.25hour Post-Dose	-1.20 ( 99999 )	88888 ( 88888 )	-0.80 ( 99999 )	0.07 ( 0.153 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.15 ( 0.071 )	0.20 ( 99999 )	88888 ( 88888 )	0.40 ( 99999 )
WEEK 109 DAY 1, 1hour Post-Dose	-1.20 ( 99999 )	88888 ( 88888 )	-0.50 ( 99999 )	0.10 ( 0.173 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.15 ( 0.071 )	0.10 ( 99999 )	88888 ( 88888 )	0.40 ( 99999 )
WEEK 133 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.60 ( 0.283 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.40 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	1.00 ( 99999 )
WEEK 133 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.25 ( 0.071 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.30 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	0.70 ( 99999 )
WEEK 133 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.45 ( 0.071 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	0.20 ( 99999 )
WEEK 153 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	0.20 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 153 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	-0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 153 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	0.00 ( 0.00 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.20 ( 99999 )	0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.10 ( 99999 )	0.05 ( 0.636 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.10 ( 99999 )	-0.05 ( 0.071 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 8, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.20 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 8, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.40 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 169 DAY 8, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.30 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 173 DAY 1, Predose	88888 ( 88888 )	-0.30 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 173 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	-0.40 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 173 DAY 1, 1hour Post-Dose	88888 ( 88888 )	-0.40 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 221 DAY 1, Predose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 221 DAY 1, 0.25hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.10 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
WEEK 221 DAY 1, 1hour Post-Dose	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	-0.20 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Primary: Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM) - All treated population

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End point title

Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM) - All treated population ^[17]

End point description

ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR >= 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 h. Confidence intervals were based on the exact method.

End point type

Primary

End point timeframe

Up to approximately 4.5 years

Notes
[17] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Number of subjects analysed

Units: Percentage of Participants

number (confidence interval 95%)

58 (27.7 to 84.8)

75 (19.4 to 99.4)

69 (38.6 to 90.9)

69 (41.3 to 89.0)

50 (21.1 to 78.9)

83 (51.6 to 97.9)

92 (61.5 to 99.8)

75 (42.8 to 94.5)

62 (31.6 to 86.1)

78 (52.4 to 93.6)

50 (21.1 to 78.9)

69 (41.3 to 89.0)

No statistical analyses for this end point

Secondary: Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A - Pharmacokinetic (PK) population

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End point title

Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A - Pharmacokinetic (PK) population ^[18]

End point description

Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. 88888 = Data was not collected for particular timepoint.

End point type

Secondary

End point timeframe

Cycle 1: Pre-Dose, 0, 2 and 24 hours post-dose on Days 1 and 8

Notes
[18] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	16
Units: Microgram/ millilitre (ug/mL)
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	43.58 ( 21.78 )	36.41 ( 17.06 )	25.22 ( 16.53 )	39.99 ( 25.03 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	27.60 ( 16.27 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC (0-672h) for belantamab mafodotin ADC, Treatment A - PK population

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End point title

AUC (0-672h) for belantamab mafodotin ADC, Treatment A - PK population ^[19]

End point description

Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28

Notes
[19] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	3	9	9
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	4093.12 ( 24.45 )	5114.28 ( 34.72 )	4699.00 ( 11.10 )	4432.11 ( 17.65 )

No statistical analyses for this end point

Secondary: Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A - PK population

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End point title

Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A - PK population ^[20]

End point description

Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21

Notes
[20] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	3	9	9
Units: Hourmicrogram/millilitre (hug/mL)
geometric mean (geometric coefficient of variation)	3848.41 ( 24.25 )	4802.83 ( 34.51 )	4365.82 ( 10.25 )	4127.66 ( 17.98 )

No statistical analyses for this end point

Secondary: Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A - PK population

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End point title

Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A - PK population ^[21]

End point description

Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected for particular timepoint.

End point type

Secondary

End point timeframe

Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8

Notes
[21] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	15
Units: Hour
median (full range (min-max))
CYCLE 1 DAY 1	2.050 (0.57 to 2.37)	1.342 (0.50 to 2.17)	1.100 (0.57 to 2.20)	2.000 (0.53 to 2.42)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	1.108 (0.57 to 23.93)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A - PK population

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End point title

Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A - PK population ^[22]

End point description

Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

End point type

Secondary

End point timeframe

Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 28

Notes
[22] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	16
Units: Hour
median (full range (min-max))	181.467 (25.50 to 698.22)	685.608 (191.58 to 697.75)	674.833 (94.40 to 1273.75)	671.717 (2.00 to 1342.83)

No statistical analyses for this end point

Secondary: Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A - PK population

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End point title

Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A - PK population ^[23]

End point description

Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.

End point type

Secondary

End point timeframe

Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8

Notes
[23] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	16
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	88888 (88888 to 88888)	1.79 (0.7 to 1.8)	3.52 (2.5 to 4.7)	1.08 (0.7 to 1.5)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	1.30 (0.7 to 2.4)	88888 (88888 to 88888)
WEEK 5 DAY 1	88888 (88888 to 88888)	77777 (77777 to 77777)	5.05 (2.4 to 7.0)	77777 (77777 to 77777)
WEEK 5 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	1.17 (0.1 to 3.6)	88888 (88888 to 88888)
WEEK 9 DAY 1	88888 (88888 to 88888)	77777 (77777 to 77777)	4.89 (3.0 to 8.4)	77777 (77777 to 77777)
WEEK 9 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	2.03 (1.8 to 3.9)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A - PK population

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End point title

Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A - PK population ^[24]

End point description

End point type

Secondary

End point timeframe

Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8

Notes
[24] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	11	4	12	15
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	39.10 (27.2 to 49.5)	36.05 (29.6 to 44.5)	25.05 (18.2 to 31.5)	41.80 (14.0 to 51.3)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	26.55 (18.6 to 35.2)	88888 (88888 to 88888)
WEEK 5 DAY 1	88888 (88888 to 88888)	35.45 (33.8 to 42.0)	23.00 (20.5 to 27.2)	36.75 (25.6 to 96.2)
WEEK 5 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	27.10 (23.6 to 41.8)	88888 (88888 to 88888)
WEEK 9 DAY 1	42.35 (31.1 to 49.5)	77777 (77777 to 77777)	23.50 (15.3 to 31.8)	77777 (77777 to 77777)
WEEK 9 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	25.60 (17.1 to 31.1)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	38.40 (28.1 to 50.9)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Cmax for belantamab mafodotin ADC. Treatment B - PK population

Top of page

End point title

Cmax for belantamab mafodotin ADC. Treatment B - PK population ^[25]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[25] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: ug/mL
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	52.24 ( 31.87 )	49.50 ( 21.38 )	61.16 ( 36.74 )	51.29 ( 26.03 )	21.34 ( 34.67 )	46.95 ( 23.24 )	27.79 ( 37.28 )	64.00 ( 38.60 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	24.46 ( 32.10 )	88888 ( 88888 )	31.96 ( 32.79 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC (0-504h) for belantamab mafodotin ADC, Treatment B - PK population

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End point title

AUC (0-504h) for belantamab mafodotin ADC, Treatment B - PK population ^[26]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

Notes
[26] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	7	10	4	7	7	15	8	11
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	6129.71 ( 23.83 )	4451.74 ( 23.33 )	6073.99 ( 37.06 )	5395.98 ( 20.49 )	4341.73 ( 22.36 )	5013.84 ( 31.91 )	5702.03 ( 26.30 )	6230.16 ( 35.02 )

No statistical analyses for this end point

Secondary: Tmax for belantamab mafodotin ADC, Treatment B - PK population

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End point title

Tmax for belantamab mafodotin ADC, Treatment B - PK population ^[27]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[27] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: Hour
median (full range (min-max))
CYCLE 1 DAY 1	1.900 (0.63 to 22.50)	1.125 (0.55 to 2.62)	2.025 (0.63 to 25.95)	1.175 (0.62 to 2.57)	1.233 (0.50 to 2.22)	1.308 (0.45 to 2.70)	0.583 (0.50 to 2.20)	2.000 (0.52 to 3.83)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	0.733 (0.52 to 336.75)	88888 (88888 to 88888)	0.642 (0.40 to 2.05)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: AUC (0-1008h) for belantamab mafodotin ADC, Treatment B - PK population

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End point title

AUC (0-1008h) for belantamab mafodotin ADC, Treatment B - PK population ^[28]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC was derived only for STRETCH and S/D STRETCH cohorts.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre Pre-Dose and Post-Dose on Week 5 Day 7

Notes
[28] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Number of subjects analysed	5	10	6
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	7084.63 ( 24.82 )	7396.49 ( 25.94 )	6487.41 ( 26.24 )

No statistical analyses for this end point

Secondary: tlast for belantamab mafodotin ADC, Treatment B - PK population

Top of page

End point title

tlast for belantamab mafodotin ADC, Treatment B - PK population ^[29]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

End point type

Secondary

End point timeframe

Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1

Notes
[29] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: Hour
median (full range (min-max))	540.250 (75.67 to 1052.33)	505.592 (503.75 to 1220.95)	1009.933 (500.93 to 1489.00)	755.442 (22.68 to 2018.57)	504.567 (144.83 to 1351.17)	506.817 (167.50 to 577.33)	503.458 (239.72 to 1584.50)	506.092 (2.00 to 2022.58)

No statistical analyses for this end point

Secondary: Ctrough for belantamab mafodotin ADC, Treatment B - PK population

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End point title

Ctrough for belantamab mafodotin ADC, Treatment B - PK population ^[30]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

Notes
[30] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	1.12 (0.5 to 1.5)	1.92 (0.6 to 3.9)	0.63 (0.5 to 1.2)	0.84 (0.5 to 1.0)	3.50 (1.8 to 7.1)	2.12 (1.1 to 5.4)	4.25 (1.6 to 11.7)	2.10 (0.5 to 4.3)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	3.72 (0.7 to 24.3)	88888 (88888 to 88888)	3.93 (1.7 to 9.0)	88888 (88888 to 88888)
WEEK 4 DAY 1	88888 (88888 to 88888)	3.23 (1.4 to 5.4)	88888 (88888 to 88888)	88888 (88888 to 88888)	4.39 (3.0 to 8.6)	1.32 (0.6 to 8.6)	3.62 (1.4 to 6.2)	2.53 (0.6 to 4.3)
WEEK 7 DAY 1	77777 (77777 to 77777)	3.90 (0.5 to 6.4)	1.24 (0.6 to 2.8)	77777 (77777 to 77777)	5.85 (4.0 to 8.1)	2.72 (0.1 to 3.7)	10.10 (5.7 to 13.9)	88888 (88888 to 88888)
WEEK 10 DAY 1	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	1.40 (0.7 to 2.1)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: C-EOI for belantamab mafodotin ADC, Treatment B - PK population

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End point title

C-EOI for belantamab mafodotin ADC, Treatment B - PK population ^[31]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8; Week 7 Day 8, Week 7 Day 11, Week 10 Day 8

Notes
[31] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	44.75 (26.8 to 68.0)	44.05 (36.1 to 61.5)	52.00 (22.8 to 88.8)	45.25 (31.4 to 76.7)	22.30 (12.9 to 30.6)	45.80 (29.1 to 57.6)	30.10 (11.0 to 49.1)	54.85 (37.2 to 215.0)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	22.60 (12.2 to 48.4)	88888 (88888 to 88888)	32.60 (17.5 to 55.7)	88888 (88888 to 88888)
WEEK 4 DAY 1	88888 (88888 to 88888)	46.00 (30.5 to 64.0)	88888 (88888 to 88888)	88888 (88888 to 88888)	27.10 (16.7 to 32.4)	44.50 (26.8 to 254.0)	26.20 (14.6 to 53.2)	51.20 (45.7 to 57.8)
WEEK 7 DAY 1	48.60 (37.9 to 83.6)	44.30 (3.4 to 71.8)	36.45 (26.5 to 76.9)	42.50 (25.9 to 84.1)	26.30 (19.1 to 29.7)	31.70 (18.2 to 62.7)	27.40 (12.1 to 38.6)	38.35 (37.0 to 55.8)
WEEK 7 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)
WEEK 7 DAY 11	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)
WEEK 10 DAY 1	88888 (88888 to 88888)	88888 (88888 to 88888)	38.00 (31.9 to 43.3)	77777 (77777 to 77777)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 10 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	77777 (77777 to 77777)	43.30 (31.1 to 60.1)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)	46.60 (41.4 to 62.3)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Cmax for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

Cmax for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[32]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[32] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	16
Units: ug/mL
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	43.09 ( 22.26 )	40.18 ( 13.23 )	26.64 ( 14.97 )	46.95 ( 30.63 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	35.11 ( 13.68 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[33]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7

Notes
[33] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
Number of subjects analysed	5
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	8143.85 ( 30.12 )

No statistical analyses for this end point

Secondary: AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[34]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28

Notes
[34] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	4	10	9
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	7408.65 ( 36.03 )	7249.58 ( 39.00 )	7828.12 ( 27.15 )	8146.00 ( 28.29 )

No statistical analyses for this end point

Secondary: AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[35]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21

Notes
[35] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	4	10	9
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	6648.19 ( 35.67 )	6607.45 ( 35.62 )	6909.91 ( 24.70 )	7277.25 ( 28.00 )

No statistical analyses for this end point

Secondary: tlast for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

tlast for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[36]

End point description

End point type

Secondary

End point timeframe

Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 3 Day 8

Notes
[36] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	16
Units: Hour
median (full range (min-max))	657.267 (25.50 to 1439.63)	685.875 (673.92 to 697.75)	674.833 (670.60 to 1416.93)	673.625 (2.00 to 1534.15)

No statistical analyses for this end point

Secondary: AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[37]

End point description

Blood samples were collected for PK analysis. PK parameter was determinedusing standard non-compartmental methods. AUC(0-1344) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7

Notes
[37] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
Number of subjects analysed	5
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	8633.05 ( 30.26 )

No statistical analyses for this end point

Secondary: Tmax for belantamab mafodotin (Total Antibody), Treatment A - PK population

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End point title

Tmax for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[38]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[38] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	16
Units: Hour
median (full range (min-max))
CYCLE 1 DAY 1	1.267 (0.57 to 2.37)	1.342 (0.50 to 2.17)	1.033 (0.57 to 2.20)	2.000 (0.53 to 2.82)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	1.583 (0.57 to 2.10)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Ctrough for belantamab mafodotin (Total Antibody), Treatment A - PK population

Top of page

End point title

Ctrough for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[39]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

Notes
[39] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	4	12	12
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	0.81 (0.6 to 2.0)	3.39 (0.7 to 6.1)	7.74 (1.9 to 9.9)	3.16 (1.6 to 5.9)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	3.99 (0.9 to 12.3)	88888 (88888 to 88888)
WEEK 5 DAY 1	88888 (88888 to 88888)	2.76 (1.1 to 8.1)	12.40 (7.7 to 22.6)	1.82 (0.8 to 4.5)
WEEK 5 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	6.16 (2.5 to 22.6)	88888 (88888 to 88888)
WEEK 9 DAY 1	77777 (77777 to 77777)	77777 (77777 to 77777)	15.25 (11.2 to 29.7)	77777 (77777 to 77777)
WEEK 9 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	10.50 (1.3 to 10.5)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	10.70 (0.9 to 17.0)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: C-EOI for belantamab mafodotin (Total Antibody), Treatment A - PK population

Top of page

End point title

C-EOI for belantamab mafodotin (Total Antibody), Treatment A - PK population ^[40]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

Notes
[40] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	10	4	13	16
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	42.70 (35.0 to 64.0)	36.90 (35.3 to 47.9)	27.25 (20.1 to 32.7)	47.00 (17.2 to 64.2)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	35.00 (27.8 to 40.3)	88888 (88888 to 88888)
WEEK 5 DAY 1	88888 (88888 to 88888)	42.15 (32.4 to 48.1)	27.00 (24.7 to 36.4)	45.70 (30.0 to 79.9)
WEEK 5 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	36.40 (27.8 to 50.6)	88888 (88888 to 88888)
WEEK 9 DAY 1	41.80 (33.1 to 52.9)	77777 (77777 to 77777)	31.25 (22.9 to 46.6)	77777 (77777 to 77777)
WEEK 9 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	39.20 (27.4 to 56.8)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	50.10 (39.5 to 73.3)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Cmax for belantamab mafodotin (Total Antibody) Treatment B - PK population

Top of page

End point title

Cmax for belantamab mafodotin (Total Antibody) Treatment B - PK population ^[41]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[41] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	10	12	12	13	17	11	16
Units: ug/mL
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	41.28 ( 16.86 )	37.47 ( 12.02 )	53.29 ( 23.50 )	53.85 ( 12.54 )	22.92 ( 35.83 )	50.32 ( 30.03 )	31.06 ( 20.02 )	78.29 ( 36.16 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	29.47 ( 40.48 )	88888 ( 88888 )	45.31 ( 39.57 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment B - PK population

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End point title

AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment B - PK population ^[42]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

Notes
[42] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	8	6	4	6	8	12	7	11
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	7310.17 ( 37.27 )	6094.55 ( 33.37 )	8386.87 ( 25.44 )	9891.43 ( 29.93 )	8283.76 ( 32.51 )	8207.69 ( 41.72 )	9812.19 ( 27.13 )	12581.08 ( 28.13 )

No statistical analyses for this end point

Secondary: AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment B - PK population

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End point title

AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment B - PK population ^[43]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7

Notes
[43] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
Number of subjects analysed	5	11	10
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	11656.56 ( 25.11 )	11328.37 ( 40.25 )	11178.97 ( 49.10 )

No statistical analyses for this end point

Secondary: Tmax for belantamab mafodotin (Total Antibody), Treatment B - PK population

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End point title

Tmax for belantamab mafodotin (Total Antibody), Treatment B - PK population ^[44]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[44] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	10	12	12	13	17	11	16
Units: Hour
median (full range (min-max))
CYCLE 1 DAY 1	1.900 (0.75 to 2.03)	2.033 (0.70 to 2.23)	0.983 (0.57 to 2.13)	1.142 (0.62 to 2.58)	2.000 (0.50 to 2.17)	1.983 (0.45 to 2.23)	0.650 (0.50 to 2.13)	2.000 (0.52 to 2.50)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	0.700 (0.52 to 2.50)	88888 (88888 to 88888)	0.617 (0.40 to 2.05)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: tlast for belantamab mafodotin (Total Antibody), Treatment B - PK population

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End point title

tlast for belantamab mafodotin (Total Antibody), Treatment B - PK population ^[45]

End point description

End point type

Secondary

End point timeframe

Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1

Notes
[45] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: Hour
median (full range (min-max))	585.958 (75.67 to 2855.48)	504.983 (239.92 to 2155.95)	1414.500 (505.25 to 3694.62)	1031.467 (1006.72 to 4054.38)	504.583 (144.83 to 1351.17)	505.483 (167.50 to 671.65)	502.883 (239.72 to 717.68)	506.808 (2.00 to 2832.25)

No statistical analyses for this end point

Secondary: Ctrough for belantamab mafodotin (Total Antibody), Treatment B - PK population

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End point title

Ctrough for belantamab mafodotin (Total Antibody), Treatment B - PK population ^[46]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

Notes
[46] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	4	10	9	11	12	14	12	15
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	3.13 (1.0 to 5.6)	5.27 (2.1 to 10.7)	1.53 (1.1 to 4.5)	1.32 (0.6 to 8.6)	5.88 (1.2 to 13.5)	7.22 (1.7 to 17.2)	9.59 (3.5 to 38.9)	6.82 (1.4 to 17.4)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	12.30 (2.7 to 33.2)	88888 (88888 to 88888)	12.05 (7.8 to 22.6)	88888 (88888 to 88888)
WEEK 4 DAY 1	88888 (88888 to 88888)	7.97 (0.6 to 18.8)	88888 (88888 to 88888)	88888 (88888 to 88888)	14.95 (1.2 to 27.7)	3.62 (0.6 to 22.8)	11.20 (5.3 to 25.1)	5.27 (1.9 to 13.2)
WEEK 7 DAY 1	77777 (77777 to 77777)	7.66 (2.6 to 22.2)	1.72 (1.4 to 6.5)	2.32 (1.9 to 5.8)	19.40 (10.3 to 34.0)	1.35 (1.1 to 21.7)	26.00 (19.1 to 31.0)	88888 (88888 to 88888)
WEEK 7 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)
WEEK 10 DAY 1	88888 (88888 to 88888)	88888 (88888 to 88888)	3.07 (1.4 to 3.4)	77777 (77777 to 77777)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	5.26 (1.3 to 10.5)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: C-EOI for belantamab mafodotin (Total Antibody), Treatment B - PK population

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End point title

C-EOI for belantamab mafodotin (Total Antibody), Treatment B - PK population ^[47]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

Notes
[47] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	11	11	12	12	12	16	11	15
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	36.60 (30.7 to 52.0)	36.75 (27.6 to 44.0)	52.55 (38.2 to 90.3)	51.65 (43.7 to 66.1)	23.90 (13.9 to 33.1)	44.35 (30.3 to 63.0)	33.40 (21.2 to 40.1)	68.80 (42.5 to 241.0)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	24.95 (16.1 to 38.2)	88888 (88888 to 88888)	42.50 (25.7 to 98.9)	88888 (88888 to 88888)
WEEK 4 DAY 1	88888 (88888 to 88888)	39.20 (24.6 to 54.6)	88888 (88888 to 88888)	88888 (88888 to 88888)	37.00 (19.8 to 46.0)	59.50 (30.1 to 233.0)	39.40 (19.6 to 70.8)	67.85 (50.0 to 85.5)
WEEK 7 DAY 1	36.50 (31.8 to 67.8)	43.00 (14.3 to 78.6)	37.30 (23.3 to 65.1)	47.50 (33.3 to 67.7)	42.00 (24.0 to 49.5)	50.75 (29.6 to 73.8)	33.90 (20.2 to 63.0)	63.95 (44.5 to 67.6)
WEEK 7 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)
WEEK 7 DAY 11	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)
WEEK 10 DAY 1	88888 (88888 to 88888)	88888 (88888 to 88888)	42.70 (41.0 to 53.6)	77777 (77777 to 77777)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)
WEEK 10 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	77777 (77777 to 77777)	33.30 (27.8 to 41.6)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)	54.50 (52.9 to 85.3)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Cmax for belantamab mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A - PK population

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End point title

Cmax for belantamab mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A - PK population ^[48]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[48] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	11	4	12	13
Units: ug/mL
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	1.11 ( 70.59 )	0.55 ( 53.90 )	0.53 ( 48.23 )	1.18 ( 53.35 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	0.63 ( 28.28 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC (0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

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End point title

AUC (0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population ^[49]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4 and Cycle 1 Day 7

Notes
[49] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	9	1	11	10
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	106.21 ( 55.99 )	88888 ( 88888 )	43.15 ( 26.42 )	113.58 ( 49.61 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	51.31 ( 30.45 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

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End point title

Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population ^[50]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[50] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	11	4	12	13
Units: Hour
median (full range (min-max))
CYCLE 1 DAY 1	24.217 (1.42 to 28.58)	24.900 (23.67 to 73.42)	23.667 (1.00 to 25.42)	24.367 (2.23 to 25.92)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	23.425 (0.57 to 25.93)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: AUC (0-336h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

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End point title

AUC (0-336h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population ^[51]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC (0-336h) was derived only for the Belantamab mafodotin 2.5mg/kg + Len/Dex SPLIT cohort.

End point type

Secondary

End point timeframe

Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14

Notes
[51] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
Number of subjects analysed	8
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	93.84 ( 29.16 )

No statistical analyses for this end point

Secondary: C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

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End point title

C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population ^[52]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

Notes
[52] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	11	4	13	14
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	0.43 (0.3 to 1.6)	0.187 (0.160 to 0.290)	0.19 (0.1 to 1.3)	0.29 (0.1 to 1.3)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	0.29 (0.2 to 0.9)	88888 (88888 to 88888)
WEEK 5 DAY 1	88888 (88888 to 88888)	0.16 (0.1 to 0.4)	0.13 (0.1 to 0.3)	0.28 (0.2 to 1.0)
WEEK 5 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	0.23 (0.2 to 0.4)	88888 (88888 to 88888)
WEEK 9 DAY 1	0.29 (0.2 to 0.5)	77777 (77777 to 77777)	0.13 (0.1 to 0.7)	77777 (77777 to 77777)
WEEK 9 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	0.24 (0.2 to 0.4)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	0.68 (0.2 to 0.9)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	0.243 (0.207 to 0.248)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: tlast for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

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End point title

tlast for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population ^[53]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15

Notes
[53] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	12	4	13	14
Units: Hour
median (full range (min-max))	165.567 (25.50 to 357.02)	120.283 (49.97 to 191.58)	336.900 (94.40 to 360.17)	166.167 (2.08 to 239.17)

No statistical analyses for this end point

Secondary: Cmax for belantamab mafodotin (Cys-mcMMAF) Treatment B - PK population

Top of page

End point title

Cmax for belantamab mafodotin (Cys-mcMMAF) Treatment B - PK population ^[54]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[54] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	10	12	12	12	11	11	11	9
Units: ug/mL
geometric mean (geometric coefficient of variation)
CYCLE 1 DAY 1	0.73 ( 29.88 )	0.75 ( 68.94 )	1.03 ( 52.77 )	1.29 ( 38.95 )	0.65 ( 87.99 )	1.15 ( 57.18 )	1.03 ( 38.56 )	1.09 ( 40.30 )
CYCLE 1 DAY 8	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	0.58 ( 87.48 )	88888 ( 88888 )	0.86 ( 64.55 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC(0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

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End point title

AUC(0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population ^[55]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7

Notes
[55] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Number of subjects analysed	8	9	10
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	89.05 ( 41.52 )	52.82 ( 96.74 )	81.17 ( 31.46 )

No statistical analyses for this end point

Secondary: Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

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End point title

Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population ^[56]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8

Notes
[56] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	10	12	12	12	11	11	11	9
Units: Hour
median (full range (min-max))
CYCLE 1 DAY 1	22.225 (22.07 to 24.77)	24.475 (1.00 to 25.75)	23.092 (22.00 to 25.95)	22.442 (1.17 to 74.02)	24.083 (19.30 to 77.37)	24.083 (2.07 to 25.25)	24.583 (22.97 to 70.28)	24.667 (21.85 to 25.72)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	24.000 (0.92 to 25.30)	88888 (88888 to 88888)	23.717 (2.58 to 25.60)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: tlast for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

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End point title

tlast for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population ^[57]

End point description

End point type

Secondary

End point timeframe

Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1

Notes
[57] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	18	12	16
Units: Hour
median (full range (min-max))	85.542 (68.57 to 262.25)	239.800 (72.33 to 243.90)	237.992 (70.58 to 265.82)	93.942 (67.95 to 242.77)	241.283 (146.33 to 527.50)	237.425 (70.53 to 241.58)	240.675 (237.55 to 503.73)	171.567 (2.00 to 266.87)

No statistical analyses for this end point

Secondary: C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

Top of page

End point title

C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population ^[58]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8

Notes
[58] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	12	12	12	13	17	11	15
Units: ug/mL
median (full range (min-max))
CYCLE 1 DAY 1	0.29 (0.1 to 0.5)	0.21 (0.1 to 2.7)	0.28 (0.2 to 0.6)	0.32 (0.1 to 1.4)	0.19 (0.1 to 0.7)	0.29 (0.1 to 0.8)	0.27 (0.1 to 0.8)	0.39 (0.2 to 0.6)
CYCLE 1 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	0.27 (0.1 to 1.5)	88888 (88888 to 88888)	0.40 (0.2 to 0.9)	88888 (88888 to 88888)
WEEK 4 DAY 1	88888 (88888 to 88888)	0.19 (0.1 to 0.4)	88888 (88888 to 88888)	88888 (88888 to 88888)	0.21 (0.1 to 0.4)	0.35 (0.1 to 1.5)	0.26 (0.2 to 0.6)	0.35 (0.2 to 0.9)
WEEK 7 DAY 1	0.20 (0.1 to 0.4)	0.21 (0.1 to 0.3)	0.17 (0.1 to 0.2)	0.31 (0.1 to 0.9)	0.27 (0.1 to 0.4)	0.24 (0.1 to 0.9)	0.20 (0.2 to 0.4)	0.36 (0.2 to 0.4)
WEEK 7 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)
WEEK 7 DAY 11	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)
WEEK 10 DAY 1	88888 (88888 to 88888)	88888 (88888 to 88888)	0.236 (0.188 to 0.238)	77777 (77777 to 77777)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	99999 (99999 to 99999)
WEEK 10 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)
WEEK 13 DAY 1	77777 (77777 to 77777)	88888 (88888 to 88888)	0.222 (0.118 to 0.240)	77777 (77777 to 77777)	88888 (88888 to 88888)	77777 (77777 to 77777)	77777 (77777 to 77777)	0.24 (0.1 to 0.3)
WEEK 13 DAY 8	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)	77777 (77777 to 77777)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: Cmax for Lenalidomide (25 mg), Treatment A - PK population

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End point title

Cmax for Lenalidomide (25 mg), Treatment A - PK population ^[59]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[59] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	5	4	13
Units: ug/mL
geometric mean (geometric coefficient of variation)	382.16 ( 54.52 )	331.53 ( 17.91 )	283.08 ( 36.55 )

No statistical analyses for this end point

Secondary: AUC(0-24h) for Lenalidomide (25 mg), Treatment A - PK population

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End point title

AUC(0-24h) for Lenalidomide (25 mg), Treatment A - PK population ^[60]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[60] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	3	8
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	2247.36 ( 65.76 )	1577.62 ( 21.66 )	2117.26 ( 38.21 )

No statistical analyses for this end point

Secondary: AUC (0-4h) for Lenalidomide (25 mg), Treatment A - PK population

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End point title

AUC (0-4h) for Lenalidomide (25 mg), Treatment A - PK population ^[61]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[61] - 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: #Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	5	3	9
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	812.22 ( 105.88 )	870.92 ( 19.36 )	620.10 ( 44.84 )

No statistical analyses for this end point

Secondary: Tmax for Lenalidomide (25 mg), Treatment A - PK population

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End point title

Tmax for Lenalidomide (25 mg), Treatment A - PK population ^[62]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[62] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	5	4	13
Units: Hour
median (full range (min-max))	0.967 (0.47 to 4.00)	1.417 (0.93 to 2.00)	3.767 (1.92 to 4.00)

No statistical analyses for this end point

Secondary: tlast for Lenalidomide (25 mg), Treatment A - PK population

Top of page

End point title

tlast for Lenalidomide (25 mg), Treatment A - PK population ^[63]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-Dose, Post dose on Cycle 1 Day 1

Notes
[63] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	5	4	13
Units: Hour
median (full range (min-max))	20.750 (3.80 to 24.00)	4.000 (3.77 to 22.57)	22.050 (3.75 to 23.55)

No statistical analyses for this end point

Secondary: Cmax for Lenalidomide (10 mg), Treatment A - PK population

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End point title

Cmax for Lenalidomide (10 mg), Treatment A - PK population ^[64]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[64] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	2
Units: ug/mL
geometric mean (geometric coefficient of variation)	193.06 ( 36.86 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC(0-24h) for Lenalidomide (10 mg), Treatment A - PK population

Top of page

End point title

AUC(0-24h) for Lenalidomide (10 mg), Treatment A - PK population ^[65]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[65] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	1
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	1660.82 ( 22.40 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: AUC (0-4h) for Lenalidomide (10 mg), Treatment A - PK population

Top of page

End point title

AUC (0-4h) for Lenalidomide (10 mg), Treatment A - PK population ^[66]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[66] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	2
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	486.46 ( 41.84 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Tmax for Lenalidomide (10 mg), Treatment A - PK population

Top of page

End point title

Tmax for Lenalidomide (10 mg), Treatment A - PK population ^[67]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

Notes
[67] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	2
Units: Hour
median (full range (min-max))	2.000 (0.53 to 3.80)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: tlast for Lenalidomide (10 mg), Treatment A - PK population

Top of page

End point title

tlast for Lenalidomide (10 mg), Treatment A - PK population ^[68]

End point description

End point type

Secondary

End point timeframe

Pre-Dose, Post dose on Cycle 1 Day 1

Notes
[68] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
Number of subjects analysed	4	2
Units: Hour
median (full range (min-max))	21.583 (21.27 to 23.68)	88888 (88888 to 88888)

No statistical analyses for this end point

Secondary: AUC (0-72h) for Bortezomib, Treatment B - PK population

Top of page

End point title

AUC (0-72h) for Bortezomib, Treatment B - PK population ^[69]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

Notes
[69] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	11	14	13
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
Intravenous	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Subcutaneous	95.10 ( 21.71 )	73.03 ( 30.79 )	73.06 ( 21.57 )

No statistical analyses for this end point

Secondary: Cmax for Bortezomib, Treatment B - PK population

Top of page

End point title

Cmax for Bortezomib, Treatment B - PK population ^[70]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post-Dose 0.5, 1, 2, 4 and 24 Hour on Cycle 1 Day 1

Notes
[70] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	11	15	15
Units: ug/mL
geometric mean (geometric coefficient of variation)
INTRAVENOUS	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
SUBCUTANEOUS	14.45 ( 50.16 )	14.89 ( 44.03 )	15.88 ( 42.07 )

No statistical analyses for this end point

Secondary: AUC (0-t) for Bortezomib, Treatment B - PK population

Top of page

End point title

AUC (0-t) for Bortezomib, Treatment B - PK population ^[71]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

Notes
[71] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	11	15	15
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
Intravenous	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Subcutaneous	89.48 ( 25.50 )	69.51 ( 31.87 )	71.70 ( 26.79 )

No statistical analyses for this end point

Secondary: Tmax for Bortezomib, Treatment B - PK population

Top of page

End point title

Tmax for Bortezomib, Treatment B - PK population ^[72]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

Notes
[72] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	11	15	15
Units: Hour
median (full range (min-max))
Intravenous	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)
Subcutaneous	0.533 (0.10 to 1.07)	0.517 (0.25 to 1.00)	0.500 (0.08 to 1.00)

No statistical analyses for this end point

Secondary: tlast for Bortezomib, Treatment B - PK population

Top of page

End point title

tlast for Bortezomib, Treatment B - PK population ^[73]

End point description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.

End point type

Secondary

End point timeframe

Pre-Dose, Post dose on Cycle 1 Day 3

Notes
[73] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	11	16	15
Units: Hour
median (full range (min-max))
Intravenous	88888 (88888 to 88888)	88888 (88888 to 88888)	88888 (88888 to 88888)
Subcutaneous	68.867 (44.07 to 72.00)	68.392 (44.35 to 73.10)	48.000 (46.17 to 75.65)

No statistical analyses for this end point

Secondary: Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin - All treated population

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End point title

Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin - All treated population

End point description

Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.

End point type

Secondary

End point timeframe

Up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	3	13	15	12	12	12	12	12	18	11	16
Units: Participants
Baseline	0	0	0	1	0	0	0	0	1	0	1	0
End of Treatment	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Change from Baseline in Ocular Surface Disease Index (OSDI) Total Scores - All treated population

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End point title

Change from Baseline in Ocular Surface Disease Index (OSDI) Total Scores - All treated population

End point description

The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Higher scores indicated greater disability. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	9	4	11	12	12	9	12	9	10	15	9	14
Units: Score on scale
arithmetic mean (standard deviation)
Baseline (Day 1)	11.1 ( 7.58 )	0.8 ( 1.56 )	7.8 ( 9.30 )	11.4 ( 14.26 )	10.8 ( 17.20 )	2.4 ( 2.79 )	7.8 ( 9.94 )	8.0 ( 5.66 )	12.4 ( 16.42 )	6.3 ( 7.71 )	8.6 ( 13.61 )	3.3 ( 5.58 )
End of Treatment	-5.2 ( 4.42 )	0.6 ( 4.10 )	6.9 ( 12.03 )	2.2 ( 7.19 )	15.2 ( 35.94 )	15.9 ( 14.80 )	18.7 ( 34.95 )	29.3 ( 39.18 )	6.1 ( 8.59 )	14.4 ( 23.26 )	48.3 ( 27.42 )	19.3 ( 14.41 )

No statistical analyses for this end point

Secondary: Titers of ADAs Against Belantamab Mafodotin - All treated population

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End point title

Titers of ADAs Against Belantamab Mafodotin - All treated population ^[74]

End point description

Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD.

End point type

Secondary

End point timeframe

Up to approximately 4.5 years

Notes
[74] - 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: Per objective of this endpoint, only analysis of belantamab mafodotin was planned to be presented.

End point values	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
Number of subjects analysed	1	1	1
Units: Titers
median (full range (min-max))	100 (100 to 100)	100 (100 to 100)	100 (100 to 100)

No statistical analyses for this end point

Secondary: Change from Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores - All treated population

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End point title

Change from Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores - All treated population

End point description

The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. 77777 = standard deviation (SD) could not be calculated for a single participant.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	10	3	11	12	11	8	9	8	7	11	7	10
Units: Score on scale
arithmetic mean (standard deviation)
Baseline (Day 1)	85.1 ( 11.42 )	89.0 ( 18.43 )	91.9 ( 10.88 )	91.0 ( 11.35 )	88.0 ( 16.92 )	95.5 ( 4.70 )	96.2 ( 5.20 )	95.3 ( 4.60 )	90.4 ( 7.67 )	94.1 ( 8.33 )	93.2 ( 7.13 )	94.7 ( 5.59 )
End of Treatment	0.2 ( 13.53 )	12.9 ( 22.42 )	-4.5 ( 4.04 )	-1.9 ( 3.43 )	1.1 ( 19.48 )	-8.4 ( 13.65 )	-18.3 ( 19.96 )	-26.0 ( 31.54 )	1.3 ( 77777 )	-13.2 ( 25.00 )	-48.9 ( 2.35 )	-11.5 ( 15.39 )

No statistical analyses for this end point

Secondary: Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - All treated population

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End point title

Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - All treated population

End point description

The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE like Anxious, Blurred Vision, Chills, Concentration, Constipation, Cough, Decreased Appetite, Discouraged, Dizziness, Fatigue, Heart Palpitations, Insomnia, Memory, Mouth/Throat Sores, Nausea, Nosebleed, Numbness & Tingling, Pain, Ringing In Ears, Shortness Of Breath, Vomiting and Watery Eyes. Number of participants with symptomatic AEs are presented.

End point type

Secondary

End point timeframe

Up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Anxious	8	4	13	13	8	12	12	11	11	17	10	15
Blurred Vision	0	0	0	0	0	0	0	0	0	0	0	0
Chills	8	4	13	13	8	12	12	11	11	17	10	15
Concentration	0	0	0	0	0	0	0	0	0	0	0	0
Constipation	0	0	0	0	0	0	0	0	0	0	0	0
Cough	0	0	0	0	0	0	0	0	0	0	0	0
Decreased Appetite	0	0	0	0	0	0	0	0	0	0	0	0
Discouraged	8	4	13	13	8	12	12	11	11	17	10	15
Dizziness	0	0	0	0	0	0	0	0	0	0	0	0
Fatigue	0	0	0	0	0	0	0	0	0	0	0	0
Heart Palpitations	8	4	13	13	8	12	12	11	11	17	10	15
Insomnia	0	0	0	0	0	0	0	0	0	0	0	0
Memory	0	0	0	0	0	0	0	0	0	0	0	0
Mouth/Throat Sores	0	0	0	0	0	0	0	0	0	0	0	0
Nausea	8	4	13	13	8	12	12	11	11	17	10	15
Nosebleed	8	4	13	13	8	12	12	11	11	17	10	15
Numbness & tingling	0	0	0	0	0	0	0	0	0	0	0	0
Pain	8	4	13	13	8	12	12	11	11	17	10	15
Ringing In Ears	0	0	0	0	0	0	0	0	0	0	0	0
Shortness Of Breath	0	0	0	0	0	0	0	0	0	0	0	0
Vomiting	8	4	13	13	8	12	12	11	11	17	10	15
Watery Eyes	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of participants with AEs of special interest (AESI) - All treated population

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End point title

Number of participants with AEs of special interest (AESI) - All treated population

End point description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI for belantamab mafodotin (corneal events, thrombocytopenia and infusion related reactions) are presented.

End point type

Secondary

End point timeframe

Up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Corneal Events	9	3	12	11	9	12	12	12	10	17	10	16
Thrombocytopenia	4	2	7	11	9	12	10	11	11	13	12	14
Infusion Related Reactions	1	0	2	3	0	2	1	2	2	3	3	1

No statistical analyses for this end point

Secondary: Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores - All treated population

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End point title

Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores - All treated population

End point description

BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline <0.12 logMAR score; a possible worsened vision was defined as a change from baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from baseline >=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	9	4	13	14	11	12	12	12	12	18	11	16
Units: Participants
Right Eye\|No change/improved vision	2	2	5	3	4	3	2	2	4	3	2	1
Left Eye\|No change/improved vision	2	1	2	4	4	1	2	5	4	3	3	2
Right Eye\|Possible worsened vision	3	0	0	2	2	2	0	4	2	2	5	5
Left Eye\|Possible worsened vision	2	0	2	1	0	3	5	1	2	3	2	6
Right Eye\|Definite worsened vision	4	2	8	9	5	7	10	6	6	13	4	10
Left Eye\|Definite worsened vision	5	3	9	9	7	8	5	6	6	12	6	8

No statistical analyses for this end point

Secondary: Number of Participants With Worst-case post-baseline Change in BCVA Scores by Snellen results - All treated population

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End point title

Number of Participants With Worst-case post-baseline Change in BCVA Scores by Snellen results - All treated population

End point description

BCVA score was assessed individually for better seeing eye and worse seeing eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change post baseline categories are presented for better eye and worse eye. BCVA test scores by Snellen results were categorized as improved BCVA, <= 2 lines decline in visual acuity from baseline, >= 3 lines decline in visual acuity from baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	9	4	13	14	11	12	12	12	12	18	11	16
Units: Participants
Better Eye\|Improved BCVA	0	0	1	0	0	0	0	0	1	1	0	0
Worse Eye\|Improved BCVA	0	0	1	0	1	0	0	0	1	0	0	0
Better Eye\|<=2 Lines decline	8	3	9	11	7	7	10	8	9	8	9	12
Worse Eye\|<=2 Lines decline	5	3	4	5	6	5	8	7	6	6	7	8
Better Eye\|>=3 Lines decline	1	1	3	3	4	5	2	4	2	9	2	4
Worse Eye\|>=3 Lines decline	4	1	8	9	4	7	4	5	5	12	4	8

No statistical analyses for this end point

Secondary: Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception - All treated population

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End point title

Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception - All treated population

End point description

Number of participants with a Decline in BCVA to 'Light Perception (LP)' or 'No Light Perception (NLP)' due to a Corneal Event Anytime Post-Baseline are presented. BCVA score was assessed individually for each eye. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Number of participants analyzed were who have any post-baseline BCVA score, where the Visual Acuity is due to corneal findings.

End point type

Secondary

End point timeframe

Baseline and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	9	3	10	11	11	10	12	11	8	11	8	10
Units: Participants
Left Eye, LP	0	0	0	0	0	0	0	0	0	0	0	0
Left Eye, NLP	0	0	0	0	0	0	0	0	0	0	0	0
Right Eye, LP	0	0	1	0	0	0	0	0	0	0	0	0
Right Eye, NLP	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) - All treated population

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End point title

Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) - All treated population

End point description

Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	12	4	13	16	12	12	12	12	13	18	12	16
Units: Participants
Active Edema, Right Eye	0	0	0	2	0	0	0	0	0	2	0	0
Active Edema, Left Eye	0	0	1	1	0	0	0	0	0	0	0	0
Active Opacity, Right Eye	0	0	0	3	0	0	0	0	0	3	0	1
Active Opacity, Left Eye	0	1	1	2	0	0	0	0	0	2	0	1
Corneal Neovascularization, Right Eye	0	0	0	0	0	0	0	0	2	0	0	2
Corneal Neovascularization, Left Eye	0	0	0	0	0	0	0	0	0	0	0	2
Corneal Ulcer, Right Eye	0	0	1	0	0	0	0	0	2	0	0	0
Corneal Ulcer, Left Eye	0	0	1	0	0	0	1	0	0	0	0	0
Epithelial Microcystic Edema, Right Eye	2	1	3	6	2	3	3	3	3	9	3	9
Epithelial Microcystic Edema, Left Eye	2	2	2	6	4	3	4	2	4	8	3	9
Subepithelial Haze, Right Eye	3	1	5	8	5	8	3	6	5	9	8	9
Subepithelial Haze, Left Eye	3	2	6	9	6	9	5	4	4	10	8	10

No statistical analyses for this end point

Secondary: Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings - All treated population

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End point title

Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings - All treated population

End point description

Participants with worse grade punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	9	4	13	14	11	12	12	12	12	18	11	16
Units: Participants
Right Eye\|None	2	0	2	0	0	1	0	0	2	0	1	1
Left Eye\|None	1	0	2	0	2	2	0	0	2	0	1	0
Worst eye\|None	1	0	2	0	0	1	0	0	2	0	1	0
Right Eye\|Mild	1	2	5	6	5	3	5	1	2	3	2	2
Left Eye\|Mild	3	2	1	4	5	3	5	2	1	3	2	2
Worst eye\|Mild	1	2	1	4	5	3	5	1	1	2	2	2
Right Eye\|Moderate	5	2	3	6	5	7	4	7	5	9	6	9
Left Eye\|Moderate	4	2	9	6	3	5	5	5	7	9	6	10
Worst eye\|Moderate	6	2	7	6	5	6	3	6	6	10	6	9
Right Eye\|Severe	1	0	3	2	1	1	3	4	3	6	2	4
Left Eye\|Severe	1	0	1	4	1	2	2	5	2	6	2	4
Worst eye\|Severe	1	0	3	4	1	2	4	5	3	6	2	5

No statistical analyses for this end point

Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score - All treated population

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End point title

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score - All treated population

End point description

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	10	3	10	8	12	9	11	11	9	10	10	8
Units: Score on scale
arithmetic mean (standard deviation)
GHS/QoL, Baseline (Day 1)	65.8 ( 25.29 )	69.4 ( 31.55 )	58.3 ( 14.16 )	60.4 ( 13.18 )	56.2 ( 23.33 )	67.6 ( 9.72 )	63.6 ( 20.84 )	56.1 ( 20.78 )	60.2 ( 26.61 )	55.0 ( 24.60 )	63.3 ( 16.29 )	67.7 ( 15.71 )
GHS/QoL, CFB to EoT	-50.0 ( 22.05 )	4.2 ( 17.68 )	-4.2 ( 14.43 )	-16.7 ( 18.00 )	-10.0 ( 34.05 )	-8.3 ( 11.79 )	0.0 ( 13.94 )	-14.6 ( 25.88 )	-4.2 ( 17.68 )	-8.3 ( 9.62 )	18.7 ( 23.94 )	4.2 ( 20.97 )
PF, Baseline (Day 1)	67.3 ( 23.82 )	88.9 ( 13.88 )	78.7 ( 15.65 )	73.3 ( 21.97 )	75.0 ( 15.60 )	84.4 ( 17.95 )	85.5 ( 17.34 )	70.9 ( 25.69 )	66.7 ( 31.27 )	78.7 ( 19.58 )	82.0 ( 10.91 )	89.4 ( 11.48 )
PF, CFB to EoT	-17.8 ( 48.23 )	13.3 ( 18.86 )	-6.7 ( 24.94 )	0.0 ( 33.11 )	-5.3 ( 22.80 )	-10.0 ( 14.14 )	-1.1 ( 9.81 )	-12.5 ( 27.93 )	3.3 ( 4.71 )	-10.0 ( 15.87 )	-11.7 ( 42.64 )	-1.7 ( 12.62 )
RF, Baseline (Day 1)	66.7 ( 30.43 )	88.9 ( 19.25 )	76.7 ( 22.50 )	72.9 ( 29.46 )	68.1 ( 21.86 )	72.2 ( 22.05 )	81.8 ( 24.10 )	57.6 ( 36.03 )	70.4 ( 33.10 )	73.3 ( 19.56 )	71.7 ( 22.29 )	89.6 ( 19.80 )
RF, CFB to EoT	-22.2 ( 69.39 )	16.7 ( 23.57 )	8.3 ( 34.69 )	4.2 ( 34.36 )	-6.7 ( 25.28 )	-8.3 ( 35.36 )	-11.1 ( 27.22 )	0.0 ( 32.12 )	0.0 ( 0.00 )	-20.8 ( 34.36 )	20.8 ( 36.96 )	-4.2 ( 28.46 )
EF, Baseline (Day 1)	76.7 ( 25.40 )	86.1 ( 4.81 )	77.5 ( 18.02 )	76.0 ( 16.93 )	70.8 ( 20.87 )	94.4 ( 7.22 )	73.5 ( 25.50 )	68.9 ( 28.89 )	83.3 ( 13.18 )	78.3 ( 17.21 )	83.3 ( 16.20 )	91.7 ( 8.91 )
EF, CFB to EoT	5.6 ( 29.27 )	-12.5 ( 5.89 )	0.0 ( 0.00 )	10.4 ( 15.77 )	3.3 ( 33.64 )	-16.7 ( 23.57 )	0.0 ( 11.79 )	-6.3 ( 25.49 )	-12.5 ( 5.89 )	2.1 ( 14.23 )	-12.5 ( 15.96 )	6.3 ( 12.50 )
CF, Baseline (Day 1)	75.0 ( 16.20 )	88.9 ( 9.62 )	71.7 ( 24.91 )	72.9 ( 21.71 )	81.9 ( 19.41 )	87.0 ( 13.89 )	81.8 ( 17.41 )	74.2 ( 15.57 )	74.1 ( 16.90 )	83.3 ( 22.22 )	95.0 ( 8.05 )	91.7 ( 12.60 )
CF, CFB to EoT	-16.7 ( 44.10 )	8.3 ( 11.79 )	16.7 ( 19.25 )	12.5 ( 20.97 )	-10.0 ( 25.28 )	-16.7 ( 23.57 )	2.8 ( 6.80 )	0.0 ( 17.82 )	8.3 ( 11.79 )	-8.3 ( 21.52 )	-16.7 ( 27.22 )	-8.3 ( 9.62 )
SF, Baseline (Day 1)	71.7 ( 26.12 )	88.9 ( 19.25 )	80.0 ( 18.92 )	77.1 ( 21.71 )	76.4 ( 20.67 )	83.3 ( 18.63 )	77.3 ( 28.16 )	71.2 ( 28.95 )	72.2 ( 34.36 )	68.3 ( 34.65 )	73.3 ( 17.92 )	75.0 ( 23.57 )
SF, CFB to EoT	-27.8 ( 63.10 )	8.3 ( 11.79 )	0.0 ( 23.57 )	-12.5 ( 36.96 )	-6.7 ( 25.28 )	-16.7 ( 0.00 )	-11.1 ( 22.77 )	-27.1 ( 36.66 )	0.0 ( 0.00 )	8.3 ( 16.67 )	-12.5 ( 34.36 )	16.7 ( 19.25 )
Fatigue, Baseline (Day 1)	46.7 ( 23.89 )	25.9 ( 16.97 )	31.1 ( 8.76 )	38.9 ( 19.70 )	34.3 ( 19.22 )	28.4 ( 21.60 )	29.3 ( 13.40 )	34.3 ( 26.51 )	30.9 ( 30.32 )	32.2 ( 23.10 )	37.8 ( 25.77 )	31.9 ( 3.93 )
Fatigue, CFB to EoT	3.7 ( 35.72 )	-11.1 ( 15.71 )	5.6 ( 6.42 )	2.8 ( 24.64 )	13.3 ( 28.76 )	-11.1 ( 15.71 )	-3.7 ( 13.46 )	16.7 ( 33.60 )	11.1 ( 15.71 )	2.8 ( 18.98 )	-2.8 ( 41.94 )	-11.1 ( 12.83 )
N/V, Baseline (Day 1)	11.7 ( 15.81 )	0.0 ( 0.00 )	11.7 ( 15.81 )	2.1 ( 5.89 )	8.3 ( 15.08 )	3.7 ( 7.35 )	4.5 ( 7.78 )	1.5 ( 5.03 )	5.6 ( 8.33 )	8.3 ( 11.79 )	5.0 ( 8.05 )	2.1 ( 5.89 )
N/V, CFB to EoT	11.1 ( 41.94 )	0.0 ( 0.00 )	4.2 ( 8.33 )	-4.2 ( 8.33 )	-6.7 ( 30.28 )	-8.3 ( 11.79 )	5.6 ( 17.21 )	6.3 ( 12.40 )	0.0 ( 0.00 )	-4.2 ( 8.33 )	4.2 ( 8.33 )	0.0 ( 13.61 )
Pain, Baseline (Day 1)	46.7 ( 35.83 )	22.2 ( 25.46 )	36.7 ( 24.60 )	37.5 ( 31.81 )	41.7 ( 26.11 )	24.1 ( 29.00 )	28.8 ( 25.92 )	34.8 ( 34.52 )	42.6 ( 33.45 )	28.3 ( 20.86 )	36.7 ( 25.82 )	22.9 ( 21.71 )
Pain, CFB to EoT	0.0 ( 16.67 )	-16.7 ( 47.14 )	-12.5 ( 15.96 )	-25.0 ( 50.00 )	20.0 ( 36.13 )	-16.7 ( 23.57 )	-5.6 ( 8.61 )	12.5 ( 30.54 )	-8.3 ( 11.79 )	25.0 ( 31.91 )	-4.2 ( 43.83 )	8.3 ( 16.67 )
Dyspnoea, Baseline (Day 1)	33.3 ( 35.14 )	11.1 ( 19.25 )	13.3 ( 17.21 )	12.5 ( 17.25 )	22.2 ( 25.95 )	11.1 ( 16.67 )	15.2 ( 17.41 )	33.3 ( 36.51 )	14.8 ( 24.22 )	16.7 ( 17.57 )	16.7 ( 17.57 )	8.3 ( 15.43 )
Dyspnoea, CFB to EoT	33.3 ( 33.33 )	-16.7 ( 23.57 )	25.0 ( 31.91 )	16.7 ( 19.25 )	0.0 ( 23.57 )	0.0 ( 0.00 )	-5.6 ( 13.61 )	12.5 ( 39.59 )	16.7 ( 23.57 )	0.0 ( 0.00 )	16.7 ( 19.25 )	0.0 ( 0.00 )
Insomnia, Baseline (Day 1)	40.0 ( 26.29 )	44.4 ( 38.49 )	33.3 ( 27.22 )	29.2 ( 21.36 )	36.1 ( 33.21 )	25.9 ( 14.70 )	27.3 ( 25.03 )	33.3 ( 33.33 )	37.0 ( 38.89 )	33.3 ( 31.43 )	30.0 ( 33.15 )	8.3 ( 15.43 )
Insomnia, CFB to EoT	0.0 ( 33.33 )	0.0 ( 47.14 )	-16.7 ( 19.25 )	0.0 ( 27.22 )	-6.7 ( 27.89 )	-16.7 ( 23.57 )	5.6 ( 25.09 )	8.3 ( 23.57 )	0.0 ( 47.14 )	-16.7 ( 19.25 )	0.0 ( 54.43 )	0.0 ( 0.00 )
AL, Baseline (Day 1)	23.3 ( 27.44 )	0.0 ( 0.00 )	6.7 ( 14.05 )	25.0 ( 23.57 )	13.9 ( 22.29 )	7.4 ( 14.70 )	12.1 ( 16.82 )	9.1 ( 15.57 )	22.2 ( 23.57 )	26.7 ( 26.29 )	6.7 ( 14.05 )	12.5 ( 24.80 )
AL, CFB to EoT	22.2 ( 19.25 )	16.7 ( 23.57 )	16.7 ( 19.25 )	-16.7 ( 19.25 )	0.0 ( 33.33 )	16.7 ( 23.57 )	0.0 ( 0.00 )	-4.2 ( 21.36 )	0.0 ( 0.00 )	-8.3 ( 41.94 )	25.0 ( 50.00 )	-8.3 ( 16.67 )
Constipation, Baseline (Day 1)	20.0 ( 28.11 )	0.0 ( 0.00 )	6.7 ( 14.05 )	12.5 ( 17.25 )	16.7 ( 26.59 )	11.1 ( 16.67 )	12.1 ( 16.82 )	9.1 ( 15.57 )	7.4 ( 22.22 )	13.3 ( 17.21 )	20.0 ( 32.20 )	8.3 ( 15.43 )
Constipation, CFB to EoT	0.0 ( 0.00 )	16.7 ( 23.57 )	16.7 ( 33.33 )	16.7 ( 33.33 )	0.0 ( 0.00 )	0.0 ( 47.14 )	0.0 ( 0.00 )	4.2 ( 21.36 )	0.0 ( 0.00 )	0.0 ( 0.00 )	-25.0 ( 31.91 )	16.7 ( 19.25 )
Diarrhoea, Baseline (Day 1)	6.7 ( 14.05 )	0.0 ( 0.00 )	16.7 ( 23.57 )	8.3 ( 15.43 )	19.4 ( 22.29 )	11.1 ( 16.67 )	9.1 ( 15.57 )	21.2 ( 34.23 )	11.1 ( 33.33 )	6.7 ( 21.08 )	6.7 ( 14.05 )	12.5 ( 17.25 )
Diarrhoea, CFB to EoT	22.2 ( 19.25 )	33.3 ( 47.14 )	8.3 ( 31.91 )	8.3 ( 16.67 )	-13.3 ( 29.81 )	-16.7 ( 23.57 )	-5.6 ( 13.61 )	0.0 ( 30.86 )	0.0 ( 0.00 )	0.0 ( 27.22 )	16.7 ( 19.25 )	-8.3 ( 31.91 )
FD, Baseline (Day 1)	30.0 ( 33.15 )	11.1 ( 19.25 )	30.0 ( 36.68 )	0.0 ( 0.00 )	36.1 ( 30.01 )	7.4 ( 14.70 )	24.2 ( 36.79 )	15.2 ( 17.41 )	25.9 ( 27.78 )	26.7 ( 37.84 )	20.0 ( 35.83 )	20.8 ( 35.36 )
FD, CFB to EoT	33.3 ( 57.74 )	0.0 ( 0.00 )	8.3 ( 31.91 )	0.0 ( 0.00 )	-13.3 ( 18.26 )	0.0 ( 0.00 )	0.0 ( 0.00 )	4.2 ( 21.36 )	0.0 ( 0.00 )	16.7 ( 19.25 )	8.3 ( 16.67 )	-16.7 ( 33.33 )

No statistical analyses for this end point

Secondary: Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score - All treated population

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End point title

Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score - All treated population

End point description

The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 4.5 years

End point values	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
Number of subjects analysed	10	3	10	9	12	9	11	9	9	10	10	8
Units: Score on scale
arithmetic mean (standard deviation)
DS, Baseline (Day 1)	45.0 ( 25.45 )	24.1 ( 22.45 )	26.6 ( 12.22 )	24.7 ( 19.47 )	40.7 ( 19.58 )	21.0 ( 19.40 )	21.2 ( 17.88 )	31.5 ( 21.15 )	29.0 ( 23.37 )	26.7 ( 15.89 )	25.6 ( 20.15 )	18.8 ( 8.88 )
DS, CFB to EoT	-14.8 ( 17.86 )	-8.3 ( 27.50 )	10.0 ( 9.34 )	-5.6 ( 36.00 )	23.3 ( 26.76 )	-2.8 ( 19.64 )	-8.3 ( 10.39 )	5.6 ( 22.22 )	5.6 ( 15.71 )	-2.8 ( 18.43 )	12.5 ( 20.48 )	4.2 ( 13.13 )
SET, Baseline (Day 1)	27.5 ( 16.65 )	21.0 ( 18.64 )	19.9 ( 11.20 )	18.8 ( 13.87 )	23.6 ( 13.79 )	7.7 ( 6.87 )	12.7 ( 9.65 )	15.1 ( 9.43 )	14.9 ( 6.21 )	16.7 ( 14.21 )	13.9 ( 13.60 )	11.3 ( 8.99 )
SET, CFB to EoT	-11.4 ( 15.19 )	-14.8 ( 15.71 )	0.1 ( 7.86 )	0.0 ( 9.07 )	0.0 ( 14.60 )	1.9 ( 7.86 )	3.3 ( 5.00 )	19.0 ( 19.38 )	1.1 ( 6.81 )	-2.7 ( 8.74 )	5.6 ( 8.74 )	6.5 ( 20.14 )
BI, Baseline (Day 1)	83.3 ( 17.57 )	100.0 ( 0.00 )	76.7 ( 31.62 )	81.5 ( 24.22 )	77.8 ( 29.59 )	85.2 ( 24.22 )	69.7 ( 37.87 )	88.9 ( 16.67 )	77.8 ( 33.33 )	90.0 ( 22.50 )	93.3 ( 14.05 )	75.0 ( 34.50 )
BI, CFB to EoT	-11.1 ( 50.92 )	-16.7 ( 23.57 )	-8.3 ( 31.91 )	8.3 ( 41.94 )	6.7 ( 14.91 )	0.0 ( 0.00 )	0.0 ( 0.00 )	-9.5 ( 16.27 )	0.0 ( 0.00 )	-8.3 ( 16.67 )	-8.3 ( 16.67 )	16.7 ( 19.25 )
FP, Baseline (Day 1)	58.9 ( 29.65 )	48.1 ( 12.83 )	58.9 ( 28.71 )	72.8 ( 16.77 )	65.7 ( 17.38 )	67.9 ( 17.07 )	55.6 ( 31.03 )	59.3 ( 23.57 )	58.0 ( 34.15 )	62.2 ( 15.00 )	63.3 ( 16.60 )	66.7 ( 13.28 )
FP, CFB to EoT	-7.4 ( 51.32 )	38.9 ( 39.28 )	16.7 ( 19.25 )	13.9 ( 13.98 )	-6.7 ( 21.66 )	0.0 ( 15.71 )	1.9 ( 14.77 )	-3.2 ( 22.87 )	-5.6 ( 7.86 )	-8.3 ( 31.91 )	-2.8 ( 44.79 )	22.2 ( 15.71 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 4.5 years.

Adverse event reporting additional description

All treated population included all participants who received at least one dose of study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Reporting group description

Reporting group title

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Reporting group description

Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex

Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex

Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex

Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex

Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex

Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Total subjects affected by serious adverse events

subjects affected / exposed

6 / 13 (46.15%)

2 / 4 (50.00%)

6 / 12 (50.00%)

10 / 16 (62.50%)

7 / 13 (53.85%)

13 / 18 (72.22%)

6 / 12 (50.00%)

9 / 16 (56.25%)

8 / 12 (66.67%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma

subjects affected / exposed

0 / 13 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Malignant melanoma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bowen’s disease

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Plasmacytoma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour pain

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Squamous cell carcinoma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Hypotension

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 1

0 / 0

2 / 2

deaths causally related to treatment / all

0 / 0

Haematoma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Pyrexia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Non-cardiac chest pain

subjects affected / exposed

0 / 13 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malaise

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dyspnoea

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

1 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Epistaxis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Asthma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Haemothorax

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary oedema

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Anxiety

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Platelet count decreased

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Alanine aminotransferase increased

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Infusion related reaction

subjects affected / exposed

2 / 13 (15.38%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

1 / 2

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

2 / 18 (11.11%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ankle fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Femur fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

2 / 12 (16.67%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Contusion

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ilium fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower limb fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Procedural pain

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rib fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sternal fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial fibrillation

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

2 / 12 (16.67%)

1 / 16 (6.25%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 3

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Acute myocardial infarction

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac failure congestive

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrioventricular block second degree

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial flutter

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Cardiac arrest

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Supraventricular tachycardia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Myocardial infarction

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Headache

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Cerebrovascular accident

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Autonomic neuropathy

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebral haematoma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Sciatica

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Encephalopathy

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Neutropenia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

1 / 13 (7.69%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cytopenia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Thrombocytopenia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Iron deficiency anaemia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Vertigo

subjects affected / exposed

0 / 13 (0.00%)

1 / 4 (25.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Cataract

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Colitis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhoids

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

1 / 16 (6.25%)

2 / 12 (16.67%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Incarcerated inguinal hernia

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper gastrointestinal haemorrhage

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Constipation

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Faecaloma

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diverticulum

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

1 / 2

deaths causally related to treatment / all

0 / 0

Gastritis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Irritable bowel syndrome

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Obstruction gastric

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Hepatic failure

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Renal and urinary disorders

Urinary retention

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Back pain

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Arthralgia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal chest pain

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neck pain

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Bone pain

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Flank pain

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myopathy

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pathological fracture

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Lower respiratory tract infection

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

2 / 18 (11.11%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

2 / 12 (16.67%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 4

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

2 / 12 (16.67%)

3 / 16 (18.75%)

1 / 13 (7.69%)

2 / 18 (11.11%)

0 / 12 (0.00%)

1 / 16 (6.25%)

3 / 12 (25.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

3 / 5

0 / 0

1 / 2

1 / 5

0 / 1

2 / 5

0 / 0

1 / 1

1 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

COVID-19 pneumonia

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchitis

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COVID-19

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Campylobacter colitis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Campylobacter gastroenteritis

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

1 / 12 (8.33%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Parainfluenzae virus infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Meningitis cryptococcal

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis norovirus

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumocystis jirovecii pneumonia

subjects affected / exposed

1 / 13 (7.69%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 1

0 / 0

Pseudomonas infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

1 / 18 (5.56%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

Septic shock

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Streptococcal sepsis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urosepsis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Influenza

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

2 / 13 (15.38%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper respiratory tract infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

2 / 13 (15.38%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bacteraemia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Campylobacter infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metapneumovirus infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal bacteraemia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

2 / 12 (16.67%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Abscess limb

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

3 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Device related infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Coronavirus infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Lower respiratory tract infection viral

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory tract infection viral

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rhinovirus infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Viral upper respiratory tract infection

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Hypomagnesaemia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dehydration

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

1 / 18 (5.56%)

0 / 12 (0.00%)

1 / 16 (6.25%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercalcaemia

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

1 / 18 (5.56%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour lysis syndrome

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 13 (0.00%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diabetic ketoacidosis

subjects affected / exposed

0 / 13 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

1 / 13 (7.69%)

0 / 18 (0.00%)

0 / 12 (0.00%)

0 / 16 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex	Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex	Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex	Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex	Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex	Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex	Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex	Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex
Total subjects affected by non serious adverse events
subjects affected / exposed	13 / 13 (100.00%)	4 / 4 (100.00%)	12 / 12 (100.00%)	16 / 16 (100.00%)	13 / 13 (100.00%)	18 / 18 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	16 / 16 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Lentigo maligna
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Malignant melanoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Neuroendocrine tumour
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Skin cancer
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Seborrhoeic keratosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Plasmacytoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Squamous cell carcinoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0	0
Vascular disorders
Embolism venous
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Deep vein thrombosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0
Flushing
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0
Haematoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	1	0	0
Hot flush
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Orthostatic hypotension
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Hypertension
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	0 / 13 (0.00%)	4 / 18 (22.22%)	2 / 12 (16.67%)	2 / 12 (16.67%)	2 / 12 (16.67%)	2 / 16 (12.50%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	1	0	1	3	0	5	2	2	2	2	1	2
Hypotension
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	1	0	1	0	1	1	0	1
Phlebitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
General disorders and administration site conditions
Catheter site bruise
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0
Asthenia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	3 / 16 (18.75%)	2 / 13 (15.38%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	1	5	3	0	0	0	0	0	0	0
Catheter site pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Chest pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	0	1	0	0	0	0
Chills
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	0	6	0	0	0	0	0	1
Crepitations
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Disease progression
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Face oedema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	1	0	0
Facial pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Fatigue
subjects affected / exposed	4 / 13 (30.77%)	0 / 4 (0.00%)	0 / 12 (0.00%)	7 / 16 (43.75%)	4 / 13 (30.77%)	6 / 18 (33.33%)	5 / 12 (41.67%)	5 / 12 (41.67%)	4 / 12 (33.33%)	3 / 16 (18.75%)	3 / 12 (25.00%)	5 / 12 (41.67%)
occurrences all number	5	0	0	10	5	6	5	5	5	3	3	6
Feeling abnormal
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0
Gait disturbance
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Influenza like illness
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	4	0	0	0	1	0	0	1	0	0	1	0
Injection site bruising
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Injection site erythema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	3
Injection site reaction
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	0	1	1	1	0	0	2	2
Mucosal inflammation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0
Malaise
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Localised oedema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	2 / 12 (16.67%)	2 / 16 (12.50%)	2 / 13 (15.38%)	3 / 18 (16.67%)	0 / 12 (0.00%)	5 / 12 (41.67%)	4 / 12 (33.33%)	5 / 16 (31.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	1	1	2	6	2	5	0	5	5	5	0	2
Oedema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1	1	0	1	0	0	0	0	0	1
Peripheral swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	1	1	0	0	0	0
Pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	1	0
Pyrexia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	2 / 13 (15.38%)	2 / 18 (11.11%)	2 / 12 (16.67%)	0 / 12 (0.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	0 / 12 (0.00%)	3 / 12 (25.00%)
occurrences all number	1	0	0	3	2	2	2	0	2	3	0	4
Soft tissue inflammation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Hypogammaglobulinaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	1
Reproductive system and breast disorders
Erectile dysfunction
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0
Testicular pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	0	0	2	0	0	2	0	1
Pelvic pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Genital lesion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Vulvovaginal pruritus
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Testicular swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	4 / 16 (25.00%)	2 / 13 (15.38%)	2 / 18 (11.11%)	3 / 12 (25.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	4 / 12 (33.33%)
occurrences all number	1	0	2	4	2	2	3	3	0	2	0	5
Cough
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	3 / 12 (25.00%)	2 / 16 (12.50%)	4 / 13 (30.77%)	3 / 18 (16.67%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	1	2	3	3	4	4	2	0	1	0	1	3
Atelectasis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Haemoptysis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0	0
Hiccups
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1	0	0	0	0	0	2	0	1
Hypoxia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	3 / 13 (23.08%)	2 / 18 (11.11%)	1 / 12 (8.33%)	3 / 12 (25.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	2	0	1	1	3	3	1	3	0	1	3	0
Nasal congestion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Dyspnoea exertional
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	1	1	0	0	0	1	1	0	0	0
Oropharyngeal pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	3 / 18 (16.67%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0	0	5	1	1	0	1	0	0
Nasal ulcer
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Oropharyngeal discomfort
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Pleuritic pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0
Pneumothorax
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Productive cough
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	3 / 18 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	4	0	0	1	1	0	0
Throat irritation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Sinus congestion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	1	0	0	0	1	1	0	1	0	0	0
Wheezing
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Psychiatric disorders
Confusional state
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Anxiety
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	2	0	0	2	0	0	0	0	0	0
Agitation
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	4	0	0	1	1	2	1	0	0	2	1	1
Delirium
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0
Depression
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	0	2	0	0	0	0	0	1
Insomnia
subjects affected / exposed	1 / 13 (7.69%)	2 / 4 (50.00%)	5 / 12 (41.67%)	6 / 16 (37.50%)	3 / 13 (23.08%)	6 / 18 (33.33%)	1 / 12 (8.33%)	4 / 12 (33.33%)	3 / 12 (25.00%)	4 / 16 (25.00%)	2 / 12 (16.67%)	6 / 12 (50.00%)
occurrences all number	2	4	6	7	3	6	1	4	3	4	2	6
Irritability
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	1	0	0
Mental status changes
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Mood altered
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0
Depressed mood
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Persistent depressive disorder
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Nightmare
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	4 / 16 (25.00%)	2 / 13 (15.38%)	1 / 18 (5.56%)	1 / 12 (8.33%)	3 / 12 (25.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	1 / 12 (8.33%)	3 / 12 (25.00%)
occurrences all number	2	0	0	6	2	1	1	5	2	3	1	5
Aspartate aminotransferase increased
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	2 / 13 (15.38%)	2 / 18 (11.11%)	1 / 12 (8.33%)	4 / 12 (33.33%)	5 / 12 (41.67%)	2 / 16 (12.50%)	2 / 12 (16.67%)	3 / 12 (25.00%)
occurrences all number	2	2	0	2	2	2	1	6	5	2	2	7
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	3 / 12 (25.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	0	0	1	4	0	1	1	3	1	1	0	3
Blood bilirubin increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Blood cholesterol increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	2 / 13 (15.38%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	2	0	0	3	1	0	1	3	1	0	0
Blood creatinine increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	3 / 16 (18.75%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	1	0	0	1	1	3	0	0
Blood lactate dehydrogenase increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	2	1	0	1	0	0	0	4
Blood uric acid decreased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Ejection fraction decreased
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0	2	0	0	0	0	1	1	0
Electrocardiogram QT prolonged
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	1	0	1	0	0	0	0	0	0
Grip strength decreased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Glycosylated haemoglobin increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	1 / 13 (7.69%)	0 / 18 (0.00%)	1 / 12 (8.33%)	6 / 12 (50.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	2 / 12 (16.67%)	2 / 12 (16.67%)
occurrences all number	0	0	2	4	1	0	1	6	1	2	2	2
Electrocardiogram T wave abnormal
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Intraocular pressure increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	1	0	1	0	2	1	0	1
Lipids increased
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Platelet count decreased
subjects affected / exposed	5 / 13 (38.46%)	1 / 4 (25.00%)	3 / 12 (25.00%)	4 / 16 (25.00%)	1 / 13 (7.69%)	9 / 18 (50.00%)	3 / 12 (25.00%)	7 / 12 (58.33%)	7 / 12 (58.33%)	5 / 16 (31.25%)	6 / 12 (50.00%)	9 / 12 (75.00%)
occurrences all number	7	1	3	6	1	11	3	12	12	7	13	12
Occult blood positive
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Neutrophil count decreased
subjects affected / exposed	4 / 13 (30.77%)	1 / 4 (25.00%)	4 / 12 (33.33%)	5 / 16 (31.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	1 / 16 (6.25%)	2 / 12 (16.67%)	2 / 12 (16.67%)
occurrences all number	9	2	5	14	2	5	0	2	4	4	17	2
Liver function test abnormal
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	5 / 12 (41.67%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	0	0	0	1	5	0	0	1
Visual acuity tests abnormal
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	4	0	0	0	1	25	0	0	0	13	0	0
Urine output decreased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Urine albumin/creatinine ratio increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0
Troponin T increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Weight decreased
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	1	0	1	1	1	2	1	0	0	0	1	1
Staphylococcus test positive
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
White blood cell count decreased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Weight increased
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	3 / 18 (16.67%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	0	0	3	2	0	0	1	0	1
White blood cells urine positive
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Bone contusion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	1
Chemical burns of eye
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Contusion
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	1 / 12 (8.33%)	3 / 16 (18.75%)	1 / 13 (7.69%)	4 / 18 (22.22%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1	1	5	2	5	1	1	2	2	0	1
Corneal abrasion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Eye injury
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Limb injury
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Fall
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	1 / 13 (7.69%)	2 / 18 (11.11%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	1	0	3	1	2	1	0	1	0	0	1
Infusion related reaction
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	1 / 13 (7.69%)	1 / 18 (5.56%)	3 / 12 (25.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	0	0	2	3	1	1	4	2	1	1	0	2
Joint dislocation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Ligament sprain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Overdose
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Tooth fracture
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Tendon rupture
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Skin laceration
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	1	0	0
Skin abrasion
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	2	0	0	0	0	0	0	0
Periorbital haematoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Toxicity to various agents
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Wrist fracture
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Congenital, familial and genetic disorders
Muir-Torre syndrome
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Cardiac disorders
Aortic valve disease
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Atrial fibrillation
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	2	0	1	0	0	0	1	0	0	0	0	2
Atrial flutter
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	1
Atrioventricular block first degree
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0
Extrasystoles
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Diastolic dysfunction
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Cardiac failure
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0
Atrioventricular block second degree
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Mitral valve disease
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Mitral valve incompetence
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Pericardial effusion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Palpitations
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	0	0	1	0	1	0	0	0	1
Sinus bradycardia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	2	0	0	0	0	0	0
Sinus tachycardia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Supraventricular tachycardia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Tricuspid valve incompetence
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Tachycardia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0	0	0
Ventricular arrhythmia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Ventricular hypokinesia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Nervous system disorders
Amnesia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Ageusia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Anosmia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Aphasia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Balance disorder
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Autonomic neuropathy
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Burning sensation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Carpal tunnel syndrome
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Cognitive disorder
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Depressed level of consciousness
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Dizziness
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	4 / 12 (33.33%)	1 / 16 (6.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	1 / 12 (8.33%)	3 / 12 (25.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	6	2	1	4	2	3	1	2	1	1
Dysaesthesia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Dysgeusia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	2	0	0	0	0	0	0
Headache
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	2 / 12 (16.67%)	5 / 16 (31.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	1 / 12 (8.33%)	4 / 12 (33.33%)	1 / 12 (8.33%)	3 / 16 (18.75%)	3 / 12 (25.00%)	2 / 12 (16.67%)
occurrences all number	0	1	2	5	1	2	1	4	2	3	3	2
Hypoaesthesia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	1	0	0
Lethargy
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	2 / 13 (15.38%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	1	0	1	1	2	0	1	0	1	1	1	1
Migraine
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Memory impairment
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0
Neuralgia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	1	2	1	1	0	1	1	0
Peripheral motor neuropathy
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Paraesthesia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	1	2	0	0	0	0	1	0	0	1
Neuropathy peripheral
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	3 / 13 (23.08%)	6 / 18 (33.33%)	3 / 12 (25.00%)	3 / 12 (25.00%)	2 / 12 (16.67%)	8 / 16 (50.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)
occurrences all number	0	1	0	3	5	8	5	5	2	10	1	3
Peripheral sensory neuropathy
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	1 / 12 (8.33%)	3 / 16 (18.75%)	1 / 13 (7.69%)	4 / 18 (22.22%)	2 / 12 (16.67%)	2 / 12 (16.67%)	1 / 12 (8.33%)	4 / 16 (25.00%)	2 / 12 (16.67%)	4 / 12 (33.33%)
occurrences all number	1	1	1	3	1	6	3	2	2	5	2	4
Presyncope
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	1	0
Radiculopathy
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0	0
Restless legs syndrome
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Sensory loss
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Somnolence
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Syncope
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	1	0	0	0
Tremor
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	1
Anaemia
subjects affected / exposed	4 / 13 (30.77%)	0 / 4 (0.00%)	2 / 12 (16.67%)	5 / 16 (31.25%)	3 / 13 (23.08%)	4 / 18 (22.22%)	2 / 12 (16.67%)	3 / 12 (25.00%)	2 / 12 (16.67%)	2 / 16 (12.50%)	1 / 12 (8.33%)	3 / 12 (25.00%)
occurrences all number	5	0	2	5	3	5	2	3	2	2	1	6
Lymphopenia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	2	1	0	0	0	0	0	0	0	2
Iron deficiency anaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Leukocytosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Neutropenia
subjects affected / exposed	3 / 13 (23.08%)	2 / 4 (50.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	2 / 13 (15.38%)	2 / 18 (11.11%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	18	3	0	3	3	10	2	0	0	1	0	7
Neutrophilia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Thrombocytopenia
subjects affected / exposed	2 / 13 (15.38%)	1 / 4 (25.00%)	1 / 12 (8.33%)	7 / 16 (43.75%)	9 / 13 (69.23%)	6 / 18 (33.33%)	9 / 12 (75.00%)	5 / 12 (41.67%)	3 / 12 (25.00%)	9 / 16 (56.25%)	4 / 12 (33.33%)	5 / 12 (41.67%)
occurrences all number	8	1	1	7	13	18	10	9	10	12	8	6
Ear and labyrinth disorders
Deafness unilateral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Ear haemorrhage
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Hypoacusis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
External ear pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Ear pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Middle ear effusion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Vertigo
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	2 / 12 (16.67%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	1	2	0	0	0	0	1	0	0	1	0
Tinnitus
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0
Eye disorders
Age-related macular degeneration
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Asthenopia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	2	0	0	2	0	0	0
Blepharitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	2	2	3	8	2	2	0	6	0	1
Blepharospasm
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Blindness
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Blindness unilateral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0
Cataract subcapsular
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	4	0	0	0	1	0	0
Cataract nuclear
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	8	2	0	0	2	0	0	2	0	0
Cataract cortical
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	4	0	0	5	0	0	0	0	0	0
Cataract
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	3 / 16 (18.75%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	2 / 12 (16.67%)	2 / 12 (16.67%)
occurrences all number	1	0	2	5	0	0	2	2	0	1	4	4
Chalazion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	2	3	0	2	0	3	0	0
Conjunctival hyperaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0	0	2	0	0
Conjunctival haemorrhage
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	3	0	0	1	1	1	0	1	0	0	0	0
Conjunctivitis allergic
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0
Cornea verticillata
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0
Corneal epithelium defect
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Corneal opacity
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	1	0	0
Corneal oedema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Diplopia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	3	0	0	0	0	1	0	0	0	0	0	2
Erythema of eyelid
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Dry eye
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	1 / 13 (7.69%)	4 / 18 (22.22%)	0 / 12 (0.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	4 / 16 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	2	4	2	2	9	0	5	0	7	0	2
Eye irritation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	2	2	0	0	0	2	0	2	0	0
Eye pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	3 / 13 (23.08%)	4 / 18 (22.22%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	1	0	2	6	4	10	2	2	0	4	0	3
Foreign body sensation in eyes
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	2 / 12 (16.67%)	1 / 16 (6.25%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	6	0	3	2	2	1	0	2	0	2	0	0
Eye pruritus
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	2	2	0	0	0	0	0	0	1
Glaucoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	2
Keratitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Night blindness
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0	0	0	0
Meibomian gland dysfunction
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	2	0	2	5	0	0	0	6	0	2
Lacrimation increased
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0
Keratopathy
subjects affected / exposed	12 / 13 (92.31%)	3 / 4 (75.00%)	9 / 12 (75.00%)	11 / 16 (68.75%)	10 / 13 (76.92%)	15 / 18 (83.33%)	10 / 12 (83.33%)	12 / 12 (100.00%)	12 / 12 (100.00%)	15 / 16 (93.75%)	9 / 12 (75.00%)	11 / 12 (91.67%)
occurrences all number	122	52	114	224	97	188	130	85	123	143	61	111
Ocular hyperaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0
Ocular discomfort
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0	0	0	0
Periorbital oedema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	2	2	0	0	0	0
Periorbital swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	2	0
Photophobia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	4 / 13 (30.77%)	6 / 18 (33.33%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	4	0	0	0	9	12	2	2	0	2	0	1
Posterior capsule opacification
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0
Pterygium
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Punctate keratitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	3 / 18 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	6	0	0	0	0	0	0
Retinal haemorrhage
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Retinal vein occlusion
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	7 / 13 (53.85%)	1 / 4 (25.00%)	0 / 12 (0.00%)	6 / 16 (37.50%)	5 / 13 (38.46%)	12 / 18 (66.67%)	3 / 12 (25.00%)	5 / 12 (41.67%)	5 / 12 (41.67%)	7 / 16 (43.75%)	1 / 12 (8.33%)	3 / 12 (25.00%)
occurrences all number	12	2	0	27	17	56	6	9	10	24	2	7
Uveitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Visual acuity reduced
subjects affected / exposed	4 / 13 (30.77%)	1 / 4 (25.00%)	5 / 12 (41.67%)	5 / 16 (31.25%)	1 / 13 (7.69%)	2 / 18 (11.11%)	2 / 12 (16.67%)	4 / 12 (33.33%)	4 / 12 (33.33%)	3 / 16 (18.75%)	4 / 12 (33.33%)	6 / 12 (50.00%)
occurrences all number	29	23	26	77	2	2	39	24	49	7	26	39
Vitreous haemorrhage
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0
Vitreous detachment
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0	0	0	0
Visual impairment
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	4	0	1	0	1	0	2
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0
Abdominal distension
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	0	0	0	1	1	0	2	1	0	1
Abdominal pain
subjects affected / exposed	1 / 13 (7.69%)	2 / 4 (50.00%)	2 / 12 (16.67%)	1 / 16 (6.25%)	2 / 13 (15.38%)	0 / 18 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	3 / 12 (25.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	2	2	1	5	0	3	0	3	2	0	2
Abdominal pain upper
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	1	0	1	1	0	0	1	0	0
Aerophagia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Colitis microscopic
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Anal fistula
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Anal haemorrhage
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Anal incontinence
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0
Constipation
subjects affected / exposed	3 / 13 (23.08%)	2 / 4 (50.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	2 / 13 (15.38%)	6 / 18 (33.33%)	0 / 12 (0.00%)	2 / 12 (16.67%)	5 / 12 (41.67%)	7 / 16 (43.75%)	3 / 12 (25.00%)	8 / 12 (66.67%)
occurrences all number	3	2	3	3	4	6	0	2	7	8	3	8
Diverticulum intestinal
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Dry mouth
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	2	0	1	0	2	1	0
Dental caries
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Diarrhoea
subjects affected / exposed	6 / 13 (46.15%)	3 / 4 (75.00%)	5 / 12 (41.67%)	6 / 16 (37.50%)	4 / 13 (30.77%)	8 / 18 (44.44%)	1 / 12 (8.33%)	0 / 12 (0.00%)	6 / 12 (50.00%)	4 / 16 (25.00%)	6 / 12 (50.00%)	5 / 12 (41.67%)
occurrences all number	9	6	9	11	6	12	1	0	11	9	13	6
Diverticulum
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Dyspepsia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	3 / 18 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	2	0	0	1	0	4	0	0	0	1	0	1
Dysphagia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0	0	0	0
Flatulence
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0
Gastritis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	2	0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	2 / 13 (15.38%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	2 / 12 (16.67%)	1 / 12 (8.33%)
occurrences all number	1	0	2	0	2	1	1	0	0	3	2	1
Gingival bleeding
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Gingival pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	0	0	0
Gingival swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Glossodynia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Haematochezia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2
Inguinal hernia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0
Hypoaesthesia oral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Hyperaesthesia teeth
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Haemorrhoids
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0	1
Irritable bowel syndrome
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	0	0
Melaena
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Loose tooth
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Lip swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Large intestine polyp
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1
Mouth haemorrhage
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Mouth ulceration
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	2	0	0	0	1	0	0	1	0
Oral pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	0	0
Oral discomfort
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Nausea
subjects affected / exposed	4 / 13 (30.77%)	2 / 4 (50.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	3 / 13 (23.08%)	8 / 18 (44.44%)	2 / 12 (16.67%)	1 / 12 (8.33%)	5 / 12 (41.67%)	7 / 16 (43.75%)	4 / 12 (33.33%)	2 / 12 (16.67%)
occurrences all number	5	2	2	4	5	18	2	1	5	10	4	2
Tooth loss
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	1	0	0	1	0
Rectal haemorrhage
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	1	0	0	2	0	0	0	0	0	0	1	0
Proctalgia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Toothache
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0
Paraesthesia oral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Vomiting
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	2 / 13 (15.38%)	3 / 18 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	5 / 16 (31.25%)	2 / 12 (16.67%)	1 / 12 (8.33%)
occurrences all number	4	0	0	2	4	4	0	1	2	5	2	2
Hepatobiliary disorders
Gallbladder polyp
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Hyperbilirubinaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Hypertransaminasaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0
Actinic keratosis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Blister
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0	0
Blood blister
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0
Cold sweat
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Cold urticaria
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Dermatitis acneiform
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Decubitus ulcer
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	1	0
Dermatitis allergic
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Eczema
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Dry skin
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Erythema
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	0	0
Photosensitivity reaction
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Petechiae
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Night sweats
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	0	0	0	0	0	1	1	1
Rash
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	2 / 12 (16.67%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 16 (6.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	1	2	3	0	1	0	5	0	2	1	0	2
Purpura
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Pruritus
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	1	0	0	1	0	1	1	0	0	0	0	3
Rash maculo-papular
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1	0	3	1	3	0	1	0	2	0	1
Skin disorder
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Skin lesion
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0
Skin ulcer
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	1	0	0	0
Skin plaque
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Skin mass
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Urticaria
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	1	0
Chronic kidney disease
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Dysuria
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Haematuria
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	2	0	0	1	0	0
Haemorrhage urinary tract
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Incontinence
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0
Pollakiuria
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Proteinuria
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	1	1	0	0	1	2	1	0	0	1	1	0
Urinary hesitation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Urinary incontinence
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	2	0
Urinary tract pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Urinary retention
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Endocrine disorders
Thyroid mass
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Hyperparathyroidism secondary
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 13 (23.08%)	1 / 4 (25.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	4 / 13 (30.77%)	3 / 18 (16.67%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	3	1	0	5	5	3	1	2	0	2	2	1
Back pain
subjects affected / exposed	3 / 13 (23.08%)	1 / 4 (25.00%)	2 / 12 (16.67%)	1 / 16 (6.25%)	3 / 13 (23.08%)	5 / 18 (27.78%)	0 / 12 (0.00%)	2 / 12 (16.67%)	3 / 12 (25.00%)	3 / 16 (18.75%)	2 / 12 (16.67%)	2 / 12 (16.67%)
occurrences all number	3	1	2	1	3	5	0	2	3	3	3	2
Arthritis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	4	0	1	0	0	0	0	0	0
Bone cyst
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Chest wall haematoma
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Bursitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	2	0	2	0	0	0	0	0	0
Bone pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	3 / 13 (23.08%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 12 (16.67%)	2 / 16 (12.50%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	1	0	2	2	3	1	1	0	2	2	2	0
Costochondritis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Flank pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Exposed bone in jaw
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Diffuse idiopathic skeletal hyperostosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Groin pain
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	2	0	0	0	0	0	0
Limb discomfort
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Kyphosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Joint swelling
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0
Lumbar spinal stenosis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Muscle atrophy
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Muscle spasms
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	2 / 12 (16.67%)	4 / 16 (25.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	4	0	2	8	0	0	3	1	0	1	0	0
Muscular weakness
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	2 / 12 (16.67%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	2	0	0	2	1	0	0	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	1	1	0	0	1	0	0	0	2	0	1	1
Myalgia
subjects affected / exposed	1 / 13 (7.69%)	1 / 4 (25.00%)	1 / 12 (8.33%)	3 / 16 (18.75%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 12 (16.67%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	2	1	3	0	0	1	0	2	1	0	1
Neck pain
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	1	1	0	0	0	0	0	0	0
Osteoarthritis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Osteonecrosis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Osteonecrosis of jaw
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	2	0	0	1	0	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	2 / 12 (16.67%)	2 / 16 (12.50%)	3 / 13 (23.08%)	2 / 18 (11.11%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 16 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	3	0	2	2	3	2	0	1	0	2	1	1
Spondyloarthropathy
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Rotator cuff syndrome
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pain in jaw
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Tendon disorder
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0	0	0	0
Tendon pain
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Tendonitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2
Infections and infestations
Abscess
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Bacterial disease carrier
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
COVID-19
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	3 / 12 (25.00%)	3 / 16 (18.75%)	2 / 13 (15.38%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	4 / 12 (33.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)
occurrences all number	2	0	3	3	3	0	1	0	4	0	0	3
Bronchitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Campylobacter colitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1	3	0	0	0	0	0	0	0	1
Candida infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
Campylobacter infection
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Clostridium difficile infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0	1	0	0
Conjunctivitis bacterial
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0
Cystitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Device related infection
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0
Enterovirus infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Escherichia urinary tract infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	1	0
Eye infection
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	1	2	0	0	0	0
Epididymitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Folliculitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Gingivitis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	1	0
Helicobacter gastritis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Herpes ophthalmic
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Herpes simplex reactivation
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	1	0	1	1	0	0	0	0	0	1
Gastrointestinal infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Influenza
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	2	0	0	0	0	0	2	0	2
Kidney infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Lip infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 13 (0.00%)	2 / 18 (11.11%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	2	0	4	2	0	1	2	1	0
Lower respiratory tract infection viral
subjects affected / exposed	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Nail infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	1	2	0	0	1	1	0	0	0	0
Nosocomial infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Oral candidiasis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	1 / 13 (7.69%)	0 / 18 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	1	1	0	1	0	1	0	0	0
Oral herpes
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Parainfluenzae virus infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Periodontitis
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Picornavirus infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Pneumonia viral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	1	0	1	0	1	1	1	0	1	0	1	1
Prostate infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0
Respiratory tract infection
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	0	1	0	1	1	0	0	0	0	0	2
Respiratory tract infection viral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	1	0
Rhinitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	1
Rhinovirus infection
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	2	0	0	0	2	1	0	0	0	1	1	0
Sepsis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Sinusitis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0
Skin infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	0
Tinea pedis
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Streptococcal bacteraemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Tooth infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
Upper respiratory tract infection
subjects affected / exposed	2 / 13 (15.38%)	1 / 4 (25.00%)	2 / 12 (16.67%)	3 / 16 (18.75%)	2 / 13 (15.38%)	9 / 18 (50.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	6 / 16 (37.50%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	4	1	2	4	2	11	4	0	2	6	1	2
Urinary tract infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	4 / 12 (33.33%)	2 / 16 (12.50%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 16 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	8	2	1	2	0	1	1	3	0	1
Viral upper respiratory tract infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	2 / 18 (11.11%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	1	0	0	1	0	0
Varicella zoster virus infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Viral infection
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0	0
Urinary tract infection viral
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	1	0	0
Decreased appetite
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	3 / 16 (18.75%)	0 / 13 (0.00%)	5 / 18 (27.78%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	1 / 12 (8.33%)	3 / 12 (25.00%)
occurrences all number	1	0	0	3	0	7	1	0	0	3	1	3
Appetite disorder
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Gout
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Glucose tolerance impaired
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Folate deficiency
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Fluid retention
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Diabetes mellitus
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	2 / 13 (15.38%)	0 / 4 (0.00%)	1 / 12 (8.33%)	2 / 16 (12.50%)	0 / 13 (0.00%)	1 / 18 (5.56%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 16 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	2	0	1	2	0	1	1	1	2	0	1	0
Hypertriglyceridaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Hyperuricaemia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	1 / 18 (5.56%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	1	0	0	0
Hypercholesterolaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	1
Hypoalbuminaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Hypercalcaemia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	2 / 13 (15.38%)	1 / 18 (5.56%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	2	1	0	1	0	0	0	0
Hypocalcaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 16 (6.25%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	2	0	1	0	0	0	0	1	0	1
Hypoglycaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Hypokalaemia
subjects affected / exposed	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 12 (8.33%)	4 / 16 (25.00%)	1 / 13 (7.69%)	3 / 18 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	2 / 16 (12.50%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	1	0	1	4	1	3	0	0	2	3	1	4
Hypomagnesaemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	4 / 16 (25.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	1	4	1	0	0	0	0	0	0	2
Hyponatraemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	2 / 16 (12.50%)	1 / 13 (7.69%)	2 / 18 (11.11%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	4 / 16 (25.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	4	1	4	0	0	0	6	0	1
Hypophosphataemia
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	2 / 13 (15.38%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 16 (6.25%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	0	0	2	1	6	0	0	0	1	1	0	2
Magnesium deficiency
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Iron deficiency
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Steroid diabetes
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	1 / 13 (7.69%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Vitamin B12 deficiency
subjects affected / exposed	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 13 (0.00%)	0 / 18 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 16 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

07 May 2018

Protocol Amendment 1 include following: • additional authors who contributed to protocol amendment were added • change in the Primary Medical Monitor • Changes made in the Schedule of Activities tables. The SOA tables have been modified to reflect that the disease assessments need to be performed at regular intervals instead of being linked to the administration of study drugs. Revisions have also been made in the timings and frequency of some assessments. • Minor correction made in the participants’ eligibility criteria; participants with prior allogenic SCT will now be excluded (Section 6). • Clarification made on dose delays of study drugs by giving examples of different scenarios (Section 7.2). • All routine and disease evaluation related blood and urine tests now will be done locally; centrally only if unable to perform locally (Table 16) • Administrative changes made throughout the document.

26 Apr 2019

Protocol Amendment 3 included following changes: i) Protocol was amended to change ECOG eligibility criteria in Arm A from 0-2 to 0-1 ii) to include additional guidance for management of neutropenia / prophylaxis of infections to be implemented across the study on resuming Arm A and iii) more stringent hematological monitoring for both Arm A and Arm B. Administration of belantamab mafodotin divided as two equal administrations a week apart will also be evaluated to see if this dosing schedule would result in improvement of benefit/risk due to ~25% reduction in the maximum concentration while maintaining similar exposure over a cycle compared to the full administration on Day 1. Protocol Amendment 2 also incorporates the Protocol Clarification letter previously issued to study sites, that provided updated guidance on grading corneal events and dosing participants with belantamab mafodotin. Administrative corrections and general program updates are also included in Amendment 2.

13 Jul 2020

Protocol Amendment 3 included following changes: i) Updated duration of contraception for female participants to align with this guidance of child bearing potential based on review of guidelines on aneugens. ii) Changes to ophthalmologic assessments based on these findings. iii) Reduced dose levels and extended dosing schedules for belantamab mafodotin will be evaluated in Amendment 3. • Arm A (Belantamab mafodotin + Len/Dex; 28-day cycle): A potential extended dosing schedule has been introduced via this amendment, where belantamab mafodotin at 1.9 mg/kg will be administered once every 8 weeks (STRETCH) and will be evaluated dependent on emerging data. The cycle duration will remain 28 days/4 weeks. Up to 12 participants will be enrolled in this new cohort. • Arm B (Belantamab mafodotin + Bor/Dex; 21-day cycle): 4 new dosing cohorts (2.5 mg/kg STRETCH, 2.5 → 1.9 mg/kg S/D STRETCH, 1.9 mg/kg SINGLE (Q3W dosing) and 1.9 mg/kg STRETCH) are being added. Up to 12 participants will be enrolled in each of these 4 new cohorts.

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of participants with DLTs, Treatment B - DLT-evaluable population

Primary: Number of participants with DLTs, Treatment B - DLT-evaluable population

Primary: Number of participants with dose limiting toxicities (DLTs), Treatment A - DLT-evaluable population

Primary: Number of participants with dose limiting toxicities (DLTs), Treatment A - DLT-evaluable population

Primary: Number of participants with adverse events (AEs) and serious adverse events (SAEs) - All treated population

Primary: Number of participants with adverse events (AEs) and serious adverse events (SAEs) - All treated population

Primary: Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) - All treated population

Primary: Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) - All treated population

Primary: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters - All treated population

Primary: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters - All treated population

Primary: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters - All treated population

Primary: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters - All treated population

Primary: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters - All treated population

Primary: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters - All treated population

Primary: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters - All treated population

Primary: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters - All treated population

Primary: Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein - All treated population

Primary: Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein - All treated population

Primary: Change from baseline in urine Potential of Hydrogen (pH) - All treated population

Primary: Change from baseline in urine Potential of Hydrogen (pH) - All treated population

Primary: Change from baseline in urine specific gravity - All treated population

Primary: Change from baseline in urine specific gravity - All treated population

Primary: Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP) - All treated population

Primary: Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP) - All treated population

Primary: Change from Baseline in vital Signs : Pulse Rate - All treated population

Primary: Change from Baseline in vital Signs : Pulse Rate - All treated population

Primary: Change from Baseline in vital Signs : Temperature - All treated population

Primary: Change from Baseline in vital Signs : Temperature - All treated population

Primary: Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM) - All treated population

Primary: Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM) - All treated population

Secondary: Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A - Pharmacokinetic (PK) population

Secondary: Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A - Pharmacokinetic (PK) population

Secondary: AUC (0-672h) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: AUC (0-672h) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A - PK population

Secondary: Cmax for belantamab mafodotin ADC. Treatment B - PK population

Secondary: Cmax for belantamab mafodotin ADC. Treatment B - PK population

Secondary: AUC (0-504h) for belantamab mafodotin ADC, Treatment B - PK population

Secondary: AUC (0-504h) for belantamab mafodotin ADC, Treatment B - PK population

Secondary: Tmax for belantamab mafodotin ADC, Treatment B - PK population

Secondary: Tmax for belantamab mafodotin ADC, Treatment B - PK population

Secondary: AUC (0-1008h) for belantamab mafodotin ADC, Treatment B - PK population

Secondary: AUC (0-1008h) for belantamab mafodotin ADC, Treatment B - PK population

Secondary: tlast for belantamab mafodotin ADC, Treatment B - PK population

Secondary: tlast for belantamab mafodotin ADC, Treatment B - PK population

Secondary: Ctrough for belantamab mafodotin ADC, Treatment B - PK population

Secondary: Ctrough for belantamab mafodotin ADC, Treatment B - PK population

Secondary: C-EOI for belantamab mafodotin ADC, Treatment B - PK population

Secondary: C-EOI for belantamab mafodotin ADC, Treatment B - PK population

Secondary: Cmax for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: Cmax for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: tlast for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: tlast for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

Secondary: Tmax for belantamab mafodotin (Total Antibody), Treatment A - PK population