Trial Outcomes & Findings for DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer (NCT NCT03505710)

Last Updated: 2025-05-30

Results Overview

The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

181 participants

Primary outcome timeframe

From screening, up to 36 months (data cut-off)

Results posted on

2025-05-30

Participant Flow

A total of 181 participants were enrolled and treated at clinic centers in Japan, United States, France, Netherlands, and Spain.

Duration of follow-up (months) was defined as ((last visit date - enrollment date + 1)/365.25) × 12. Last visit date was the date of last clinical visit for ongoing participants, date of death for participants who died, or the last known contact date in survival follow-up for other participants who discontinued study drug.

Participant milestones

Participant milestones
Measure	Cohort 1: HER2 Overexpressing Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Overall Study STARTED	49	41	91
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	49	41	91

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: HER2 Overexpressing Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Overall Study Progressive Disease	24	17	43
Overall Study Clinical Progression	6	8	3
Overall Study Adverse Event	12	6	28
Overall Study Withdrawal by Subject	1	3	7
Overall Study Physician Decision	1	1	2
Overall Study Death	4	5	6
Overall Study Other Reasons	1	1	1
Overall Study Study Terminated by Sponsor	0	0	1

Baseline Characteristics

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: HER2 Overexpressing n=49 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Total n=181 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants	109 Participants n=4 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants	72 Participants n=4 Participants
Age, Continuous	62.2 Years STANDARD_DEVIATION 9.58 • n=5 Participants	60.3 Years STANDARD_DEVIATION 10.22 • n=7 Participants	60.3 Years STANDARD_DEVIATION 11.94 • n=5 Participants	60.8 Years STANDARD_DEVIATION 10.94 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	60 Participants n=5 Participants	98 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	22 Participants n=7 Participants	31 Participants n=5 Participants	83 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	4 Participants n=7 Participants	31 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	31 Participants n=7 Participants	40 Participants n=5 Participants	102 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Netherlands	10 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants	31 participants n=4 Participants
Region of Enrollment United States	19 participants n=5 Participants	13 participants n=7 Participants	35 participants n=5 Participants	67 participants n=4 Participants
Region of Enrollment Japan	12 participants n=5 Participants	3 participants n=7 Participants	23 participants n=5 Participants	38 participants n=4 Participants
Region of Enrollment France	0 participants n=5 Participants	3 participants n=7 Participants	15 participants n=5 Participants	18 participants n=4 Participants
Region of Enrollment Spain	8 participants n=5 Participants	14 participants n=7 Participants	5 participants n=5 Participants	27 participants n=4 Participants

PRIMARY outcome

Timeframe: From screening, up to 36 months (data cut-off)

Population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 December 2021.

Outcome measures

Outcome measures
Measure	Cohort 1: HER2 Overexpressing n=49 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)	26.5 Percentage of Participants Interval 15.0 to 41.1	34.1 Percentage of Participants Interval 16.1 to 45.5	54.9 Percentage of Participants Interval 44.2 to 65.4

SECONDARY outcome

Timeframe: From screening, up to 36 months (data cut-off)

Population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported.

Outcome measures

Outcome measures
Measure	Cohort 1: HER2 Overexpressing n=49 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)	28.6 Percentage of Participants Interval 16.6 to 43.3	31.7 Percentage of Participants Interval 18.1 to 48.1	61.5 Percentage of Participants Interval 50.8 to 71.6

SECONDARY outcome

Timeframe: From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off)

Population: Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 03 May 2021.

Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported.

Outcome measures

Outcome measures
Measure	Cohort 1: HER2 Overexpressing n=13 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=12 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=50 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) Independent Central Review	5.8 months Interval 4.3 to Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.	4.7 months Interval 4.0 to Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.	9.3 months Interval 5.7 to 14.7
Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) Investigator Assessment	5.8 months Interval 4.7 to 11.3	7.0 months Interval 4.2 to Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.	11.7 months Interval 7.2 to 16.9

SECONDARY outcome

Timeframe: From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off)

Population: Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported.

Outcome measures

Outcome measures
Measure	Cohort 1: HER2 Overexpressing n=49 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) Independent Central Review	5.7 months Interval 2.8 to 7.2	6.7 months Interval 4.5 to Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.	8.2 months Interval 6.0 to 11.9
Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) Investigator Assessment	5.7 months Interval 3.8 to 7.2	7.2 months Interval 4.1 to 8.4	9.3 months Interval 7.1 to 14.0

SECONDARY outcome

Timeframe: From date of enrollment to death from any cause, up to 36 months (data cut-off)

Population: Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Cohort 1: HER2 Overexpressing n=49 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC)	12.4 months Interval 7.8 to 17.2	NA months Interval 6.7 to Median OS and upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.	17.8 months Interval 13.8 to 22.1

SECONDARY outcome

Timeframe: From first dose, up to 36 months (data cut-off)

Population: Disease control rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021.

Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported.

Outcome measures

Outcome measures
Measure	Cohort 1: HER2 Overexpressing n=49 Participants Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 Participants Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 Participants Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) Independent Central Review	68.9 Percentage of Participants Interval 53.4 to 81.8	77.5 Percentage of Participants Interval 61.6 to 89.2	93.0 Percentage of Participants Interval 85.4 to 97.4
Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) Investigator Assessment	75.5 Percentage of Participants Interval 61.1 to 86.7	78.0 Percentage of Participants Interval 62.4 to 89.4	94.5 Percentage of Participants Interval 87.6 to 98.2

Adverse Events

Cohort 1: HER2 Overexpressing

Serious events: 28 serious events

Other events: 46 other events

Deaths: 42 deaths

Cohort 1a: HER2 Overexpressing

Serious events: 18 serious events

Other events: 41 other events

Deaths: 32 deaths

Cohort 2: HER2 Mutated

Serious events: 40 serious events

Other events: 91 other events

Deaths: 72 deaths

Serious adverse events

Other adverse events

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort 1: HER2 Overexpressing n=49 participants at risk Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 participants at risk Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 participants at risk Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Hepatobiliary disorders Cholangitis	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Disease Progression	12.2% 6/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	9.8% 4/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.7% 7/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.2% 4/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.7% 7/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Pneumonia	8.2% 4/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.2% 2/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.2% 5/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Vomiting	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 3/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Seizure	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 3/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Diarrhoea	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 3/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Nausea	4.1% 2/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.2% 2/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Central Nervous System Necrosis	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.2% 2/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Vascular disorders Hypotension	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Mental Status Changes	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Respiratory Tract Infection	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Abdominal Sepsis	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Acute Kidney Injury	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Asthenia	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Ataxia	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Bacteraemia	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Cellulitis	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Confusional State	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Covid-19 Pneumonia	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Vascular disorders Deep Vein Thrombosis	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Delirium	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Duodenal Stenosis	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Electrocardiogram T Wave Abnormal	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Empyema	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Enterocolitis Infectious	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Fatigue	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Gastrointestinal Motility Disorder	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Haemorrhoids	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Hepatic Encephalopathy	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	1.1% 1/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

Other adverse events
Measure	Cohort 1: HER2 Overexpressing n=49 participants at risk Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 1a: HER2 Overexpressing n=41 participants at risk Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.	Cohort 2: HER2 Mutated n=91 participants at risk Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Metabolism and nutrition disorders Hypoalbuminaemia	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.7% 7/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyponatraemia	4.1% 2/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.4% 4/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.4% 10/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	29.3% 12/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	19.8% 18/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 7/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	31.7% 13/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	19.8% 18/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.2% 4/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	14.3% 13/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	4.1% 2/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	8.8% 8/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	8.8% 8/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Dysphagia	6.1% 3/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	5.5% 5/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Abdominal Pain Upper	6.1% 3/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	5.5% 5/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.7% 7/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	5.5% 5/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Neutrophil Count Decreased	22.4% 11/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	30.8% 28/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations White Blood Cell Count Decreased	12.2% 6/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	19.8% 18/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Lymphocyte Count Decreased	12.2% 6/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	14.3% 13/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Weight Decreased	24.5% 12/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	19.5% 8/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	24.2% 22/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Alanine Aminotransferase Increased	10.2% 5/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	9.8% 4/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	15.4% 14/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Aspartate Aminotransferase Increased	12.2% 6/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	9.8% 4/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.7% 17/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Platelet Count Decreased	16.3% 8/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.2% 12/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Creatinine Increased	10.2% 5/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	5.5% 5/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Alkaline Phosphatase Increased	6.1% 3/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.6% 6/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Electrocardiogram Qt Prolonged	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.7% 7/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Fatigue	32.7% 16/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	48.8% 20/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.0% 30/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Asthenia	12.2% 6/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.1% 7/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.6% 16/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Malaise	18.4% 9/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	14.3% 13/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Pyrexia	2.0% 1/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.6% 16/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Oedema Peripheral	4.1% 2/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.2% 5/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	15.4% 14/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Non-Cardiac Chest Pain	6.1% 3/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.2% 5/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 3/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Decreased Appetite	44.9% 22/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	46.3% 19/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	35.2% 32/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypokalaemia	16.3% 8/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	9.8% 4/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.1% 11/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypomagnesaemia	8.2% 4/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.4% 1/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.4% 4/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Dehydration	4.1% 2/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	2.2% 2/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Nausea	57.1% 28/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	73.2% 30/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	75.8% 69/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Diarrhoea	26.5% 13/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	34.1% 14/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	42.9% 39/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Vomiting	28.6% 14/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	31.7% 13/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	46.2% 42/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Constipation	30.6% 15/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	24.4% 10/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	39.6% 36/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Abdominal Pain	4.1% 2/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.2% 5/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	8.8% 8/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Stomatitis	12.2% 6/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.6% 6/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.2% 4/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	9.8% 4/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	8.8% 8/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	8.2% 4/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.9% 2/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	4.4% 4/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	7.3% 3/41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.6% 6/91 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.