Trial Outcomes & Findings for MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (NCT NCT03767335)

NCT ID: NCT03767335

Last Updated: 2025-06-26

Results Overview

MTD was defined as the highest dose level at which no more than 1 participant experienced a DLT during the 28-day DLT assessment window.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 62 participants
• Primary outcome timeframe: Up to 28 Days
• Results posted on: 2025-06-26

Participant Flow

A total of 73 participants were screened for study eligibility, of which 11 were considered as screen failures.

The study included a Dose Escalation part and a Dose Expansion part. The Dose Escalation part of the study included Cohorts 1 and 2. It was prespecified that 3 participants who enrolled in Dose Expansion Cohort were to be included in the Dose-Limiting Toxicity (DLT) population. As prespecified, data were collected for the DLT population for the Maximum Tolerated Dose (MTD), DLT, Recommended Phase 2 Dose (RP2D) Outcome Measures,

Participant milestones

Measure	Dose Escalation Cohort 1 Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Expansion Cohort Participants received high dose of MEN1611 (Recommended Phase 2 dose \[RP2D\]) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Overall Study STARTED	3	3	56
Overall Study Received At Least 1 Dose of Study Drug	3	3	56
Overall Study DLT Population	3	3	3
Overall Study COMPLETED	0	0	23
Overall Study NOT COMPLETED	3	3	33

Reasons for withdrawal

Measure	Dose Escalation Cohort 1 Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Expansion Cohort Participants received high dose of MEN1611 (Recommended Phase 2 dose \[RP2D\]) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Overall Study Physician Decision	1	1	0
Overall Study Withdrawal by Subject	0	0	6
Overall Study Participant excluded from efficacy population	0	0	1
Overall Study Death	0	0	2
Overall Study Progressive Disease	2	2	2
Overall Study Disease progression needing additional medication	0	0	17
Overall Study Sponsor decision	0	0	2
Overall Study Other Medical Reasons	0	0	3

Baseline Characteristics

MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Dose Escalation Cohort 1 n=3 Participants Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Expansion Cohort n=56 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Total n=62 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	1 Participants n=5 Participants	2 Participants n=7 Participants	43 Participants n=5 Participants	46 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants
Age, Continuous	65 years STANDARD_DEVIATION 7.937 • n=5 Participants	59.33 years STANDARD_DEVIATION 14.468 • n=7 Participants	53.36 years STANDARD_DEVIATION 11.112 • n=5 Participants	56.02 years STANDARD_DEVIATION 55.50 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	56 Participants n=5 Participants	62 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	50 Participants n=5 Participants	56 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 28 Days

Population: DLT population included all participants from Dose Escalation Cohorts 1, 2 and 3 participants from the Dose Expansion Cohort. DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment.

MTD was defined as the highest dose level at which no more than 1 participant experienced a DLT during the 28-day DLT assessment window.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=9 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
MTD of MEN1611 in Combination With Trastuzumab ± Fulvestrant	48 milligrams (mg)	—	—

PRIMARY outcome

Timeframe: Up to 28 days

Population: DLT population included all participants from Dose Escalation Cohorts 1, 2 and 3 participants from the Dose Expansion Cohort. DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment.

DLT was defined as the occurrence of any of the protocol defined adverse drug reactions (ADRs) related to the combination regimens or to MEN1611 alone and unrelated to the participants' underlying disease or concomitant medication occurring during 28 days after the first MEN1611 administration.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=3 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Number of Participants With DLTs of MEN1611 in Combination With Trastuzumab ± Fulvestrant	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: DLT population included all participants from Dose Escalation Cohorts 1, 2 and 3 participants from the Dose Expansion Cohort. DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment.

RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant experienced a DLT during the DLT assessment window (28days), or the maximum dose judged to be tolerable.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=9 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
RP2D of MEN1611 in Combination With Trastuzumab ± Fulvestrant	48 mg	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure.

BOR was defined as percentage of participants who had a best overall response to therapy of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) and was defined according to Response Evaluation Criteria in Solid Tumors version 1.1 assessment locally performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands).

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=42 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant Complete Response (CR)	0 percentage of participants	0 percentage of participants	4.8 percentage of participants
Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant Partial Response (PR)	0 percentage of participants	66.7 percentage of participants	35.7 percentage of participants
Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant Stable Disease (SD)	33.3 percentage of participants	33.3 percentage of participants	47.6 percentage of participants
Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant Non-CR/Non-PD	0 percentage of participants	0 percentage of participants	0 percentage of participants
Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant Progressive Disease (PD)	66.7 percentage of participants	0 percentage of participants	9.5 percentage of participants
Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant Not Evaluable (NE)	0 percentage of participants	0 percentage of participants	2.4 percentage of participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure.

ORR was calculated as the sum of the Best Overall Response (BOR) of complete response (CR) and partial response (PR) rates. ORR was defined according to Response Evaluation Criteria in Solid Tumors version 1.1assessment performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands).

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=42 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Objective Response Rate (ORR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant	0 percentage of participants Interval 0.0 to 70.8	66.7 percentage of participants Interval 9.4 to 99.2	40.5 percentage of participants Interval 25.6 to 56.7

SECONDARY outcome

Timeframe: Up to 3 years

Population: Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure.

DCR was defined as percentage of participants whose disease shrank or remained stable over a certain time period and was calculated as the sum of the best overall response (BOR) rates of CR, PR and Stable Disease (SD) rates.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=42 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Disease Control Rate (DCR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant	33.3 percentage of participants Interval 0.8 to 90.6	100 percentage of participants Interval 29.2 to 100.0	88.1 percentage of participants Interval 74.4 to 96.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure.

DOR was defined as time from first occurrence of a BOR of PR, CR or SD as locally assessed, until the disease has been shown to progress following treatment. Participants with a previous response who did not show a relapse or die without recording a relapse were censored at their last available relapse-free tumour assessment date. Participants with only one tumour assessment after baseline showing progressive disease (PD) were not included in the calculation.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=42 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Duration of Response (DOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant	224 days Interval 0.0 to Upper confidence interval (CI) not calculable due to an insufficient number of participants with events.	NA days Interval 29.0 to Median and Upper CI not calculable due to an insufficient number of participants with events.	114 days Interval 65.0 to 244.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure.

PFS was defined as the number of days between the first study treatment administration to the date of first documented disease progression as per local assessment, relapse or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last tumour assessment date.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=42 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Progression-free Survival (PFS) of MEN1611 in Combination With Trastuzumab ± Fulvestrant	62 days Interval 53.0 to Upper CI not calculable due to an insufficient number of participants with events.	203 days Interval 106.0 to Upper CI not calculable due to an insufficient number of participants with events.	167 days Interval 116.0 to 217.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure.

OS was defined as the number of days between the first study treatment administration and death from any cause. Participants still alive who had withdrawn from the study were censored using the latest among end of study and follow-up dates. Drop-out participants were considered censored and the last available date in which the participant was known to be alive were used for calculation.

Outcome measures

Measure	Dose Escalation Cohorts 1 and 2, and Dose Expansion Cohort n=3 Participants Participants received low, medium, or high dose of MEN1611 respectively, twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 Participants Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 3 n=28 Participants Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Overall Survival (OS) of MEN1611 in Combination With Trastuzumab ± Fulvestrant	120 days Interval 112.0 to Upper CI not calculable due to an insufficient number of participants with events.	203 days Interval 143.0 to Upper CI not calculable due to an insufficient number of participants with events.	989 days Interval 513.0 to Upper CI not calculable due to an insufficient number of participants with events.

Adverse Events

Dose Escalation Cohort 1

Serious events: 2 serious events

Other events: 2 other events

Deaths: 3 deaths

Dose Escalation Cohort 2

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Expansion Cohort

Serious events: 21 serious events

Other events: 56 other events

Deaths: 28 deaths

Serious adverse events

Measure	Dose Escalation Cohort 1 n=3 participants at risk Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 participants at risk Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Expansion Cohort n=56 participants at risk Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Ileus paralytic	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders General physical health deterioration	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Generalised oedema	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Appendicitis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Bacteraemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Device related infection	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Pneumonia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Soft tissue infection	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Lipase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Brachial plexopathy	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Facial nerve disorder	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Headache	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Paraparesis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Pain of skin	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.

Other adverse events

Measure	Dose Escalation Cohort 1 n=3 participants at risk Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Escalation Cohort 2 n=3 participants at risk Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.	Dose Expansion Cohort n=56 participants at risk Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	32.1% 18/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Cardiac disorders Blepharitis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Cardiac disorders Dry eye	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	7.1% 4/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Cardiac disorders Xerophthalmia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Anal fissure	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	64.3% 36/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Discoloured vomit	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Gastrooesophageal reflux disease	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	7.1% 4/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Nausea	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	46.4% 26/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	19.6% 11/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	25.0% 14/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Asthenia	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	100.0% 3/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	26.8% 15/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Fatigue	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Influenza like illness	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Mucosal inflammation	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	16.1% 9/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Oedema peripheral	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	17.9% 10/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Pyrexia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	26.8% 15/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
General disorders Temperature regulation disorder	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Hepatobiliary disorders Cholestasis	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Bronchitis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations COVID-19	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	7.1% 4/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Conjunctivitis	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Paronychia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Pneumonia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	12.5% 7/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	19.6% 11/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Amylase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	12.5% 7/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	21.4% 12/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Blood creatinine increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	7.1% 4/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Blood phosphorus decreased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Ejection fraction decreased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Glycosylated haemoglobin increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Lipase increased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	14.3% 8/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	7.1% 4/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Investigations Weight decreased	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	25.0% 14/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hypercalcaemia	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	37.5% 21/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	12.5% 7/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Metabolism and nutrition disorders Polydipsia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Dizziness	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Dysarthria	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	16.1% 9/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Headache	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	19.6% 11/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Nervous system disorders Sciatica	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Renal and urinary disorders Dysuria	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Renal and urinary disorders Polyuria	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	7.1% 4/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	3.6% 2/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	66.7% 2/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	10.7% 6/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	26.8% 15/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	5.4% 3/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Vascular disorders Haematoma	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Vascular disorders Hot flush	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Vascular disorders Hypertension	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	8.9% 5/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
Vascular disorders Lymphoedema	0.00% 0/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	33.3% 1/3 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.	1.8% 1/56 • Up to approximately 3 years Safety Population included all participants who received at least 1 dose of MEN1611. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.

Additional Information

Clinical Sciences

Menarini Ricerche S.p.A.

Phone: +39 05556809990

Email: martine.piccart@bordet.be

Results disclosure agreements

• Principal investigator is a sponsor employee The results of the study cannot be submitted for presentation, abstract, poster exhibition, or publication by the investigator until Menarini Ricerche S.p.A. has reviewed/commented and agreed to any publication.
• Publication restrictions are in place

Restriction type: OTHER