Trial Outcomes & Findings for Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer (NCT NCT02984683)

NCT ID: NCT02984683

Last Updated: 2021-09-08

Results Overview

Predefined safety criteria was defined as occurrence of following IMP-related treatment-emergent adverse event (TEAE) (based on National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.03): Grade greater than or equal to (\>=) 3 TEAE from the System Organ Class (SOC) of eye disorders, Grade \>=3 peripheral neuropathy (Preferred Term), Grade \>=4 TEAE. Per NCI-CTCAE v4.03, Adverse Events (AE) were graded as follows: Grade 1: Mild; asymptomatic/mild symptoms; Grade 2: Moderate; minimal, local or non-invasive intervention indicated; Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Up to Cycle 2 (each cycle of 21 days)
• Results posted on: 2021-09-08

Participant Flow

The study was conducted at 13 sites in 5 countries from 23 March 2017 to 07 September 2018.

A total of 23 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study and included in Part 1. The study was prematurely terminated due to safety reasons, hence Part 2 was not conducted and no analysis was performed.

Participant milestones

Measure	SAR566658 90 mg/m^2 Participants received SAR566658 90 milligram per square meter (mg/m\^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Overall Study STARTED	11	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Measure	SAR566658 90 mg/m^2 Participants received SAR566658 90 milligram per square meter (mg/m\^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Overall Study Adverse Event	3	3
Overall Study Withdrawal by Subject	1	0
Overall Study Disease progression	7	9

Baseline Characteristics

Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer

Baseline characteristics by cohort

Measure	SAR566658 90 mg/m^2 n=11 Participants Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=12 Participants Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	Total n=23 Participants Total of all reporting groups
Age, Continuous	56.73 years STANDARD_DEVIATION 11.23 • n=5 Participants	50.33 years STANDARD_DEVIATION 15.30 • n=7 Participants	53.39 years STANDARD_DEVIATION 13.61 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Cycle 2 (each cycle of 21 days)

Population: Analysis was performed on participants evaluable for predefined safety criteria population which included participants treated in the study and had completed 2 cycles, or who experienced predefined safety criteria.

Predefined safety criteria was defined as occurrence of following IMP-related treatment-emergent adverse event (TEAE) (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03): Grade greater than or equal to (>=) 3 TEAE from the System Organ Class (SOC) of eye disorders, Grade >=3 peripheral neuropathy (Preferred Term), Grade >=4 TEAE. Per NCI-CTCAE v4.03, Adverse Events (AE) were graded as follows: Grade 1: Mild; asymptomatic/mild symptoms; Grade 2: Moderate; minimal, local or non-invasive intervention indicated; Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.

Outcome measures

Measure	SAR566658 90 mg/m^2 n=9 Participants Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=9 Participants Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings Grade>=3 related TEAE from SOC Eye disorders	2 Participants	2 Participants
Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings Grade>=3 related peripheral neuropathy	0 Participants	0 Participants
Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings Grade>=4 related TEAE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days)

Population: Analysis was performed on all-treated population which included participants who actually received at least 1 dose or any partial dose of SAR566658.

Objective Response in participants was defined as the participants with complete response (CR) and partial response (PR) as best response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). As per RECIST 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	SAR566658 90 mg/m^2 n=11 Participants Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=12 Participants Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Percentage of Participants With Objective Response	9.1 percentage of participants Interval 1.0 to 31.0	8.3 percentage of participants Interval 0.9 to 28.7

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days)

Population: Data for this outcome measure was not collected and analyzed due to early termination of the study.

Disease control in participants was defined as the participants with CR, PR and stable disease (SD) with a duration of at least 3 months. As per RECIST 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions) taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days)

Population: Data for this outcome measure was not collected and analyzed due to early termination of the study.

DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first radiological documentation of tumor progression or death (due to any cause), whichever comes first. As per RECIST 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days)

Population: Data for this outcome measure was not collected and analyzed due to early termination of the study.

PFS was defined as the time interval between the date of first study treatment administration and the date of documented tumor progression or death (due to any cause), whichever comes first. As per RECIST 1.1, progression was defined as at least a 20% increase in the sum of diameters of target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days)

Population: Data for this outcome measure was not collected and analyzed due to early termination of the study.

TTP was defined as the time interval between the date of first study treatment administration and the date of the first radiologically documented tumor progression. As per RECIST 1.1, progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days)

Population: Analysis was performed on all treated population.

AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during the on-treatment period (the time from the first treatment administration to the last treatment administration +30 days). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.

Outcome measures

Measure	SAR566658 90 mg/m^2 n=11 Participants Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=12 Participants Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (SAE) Any TEAE	11 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (SAE) Any treatment emergent SAE	1 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (SAE) Any TEAE leading to treatment discontinuation	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days)

Population: Analysis was performed on all treated population.

Keratopathy is an eye disorder that involves a blister-like swelling of the cornea (the clear layer in front of the iris and pupil). All participants received ocular primary prophylaxis in each eye in order to prevent the occurrence of keratopathies at the time of each infusion (vasoconstrictor, ophthalmic topical steroid, and cold mask on eyes) and steroid eye drops for an additional 2 days following SAR566658 administration.

Outcome measures

Measure	SAR566658 90 mg/m^2 n=11 Participants Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=12 Participants Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Number of Participants With Keratopathies (Corneal Toxicity)	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 3 treatment cycles, each cycle 21 days

Population: Data for this outcome measure was not collected and analyzed due to early termination of the study.

Outcome measures

Outcome data not reported

Adverse Events

SAR566658 90 mg/m^2

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

SAR566658 120 mg/m^2

Serious events: 6 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	SAR566658 90 mg/m^2 n=11 participants at risk Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=12 participants at risk Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Gastrointestinal disorders Abdominal Pain	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Pyrexia	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Pneumonia	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Respiratory Tract Infection	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Staphylococcal Bacteraemia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Meninges	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.

Other adverse events

Measure	SAR566658 90 mg/m^2 n=11 participants at risk Participants received SAR566658 90 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).	SAR566658 120 mg/m^2 n=12 participants at risk Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Ear and labyrinth disorders Ear Pruritus	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Endocrine disorders Cushingoid	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Abnormal Sensation In Eye	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Corneal Epithelial Microcysts	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Corneal Opacity	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Diplopia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Dry Eye	27.3% 3/11 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Halo Vision	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Keratitis	45.5% 5/11 • Number of events 5 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Keratopathy	27.3% 3/11 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	41.7% 5/12 • Number of events 6 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Periorbital Oedema	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Photophobia	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Vision Blurred	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Vitreous Floaters	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Eye disorders Xerophthalmia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Abdominal Pain	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Constipation	27.3% 3/11 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	16.7% 2/12 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Dry Mouth	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	16.7% 2/12 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Odynophagia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Stomatitis	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Gastrointestinal disorders Vomiting	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Asthenia	36.4% 4/11 • Number of events 4 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	25.0% 3/12 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Device Related Thrombosis	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Fatigue	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Hyperthermia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Oedema Peripheral	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
General disorders Pain	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Cystitis	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Folliculitis	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Gastrointestinal Infection	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Nasopharyngitis	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Periodontitis	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Sinusitis	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Skin Infection	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Tonsillitis	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Infections and infestations Urinary Tract Infection	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Injury, poisoning and procedural complications Intentional Overdose	9.1% 1/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Investigations Blood Bilirubin Increased	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Investigations Transaminases Increased	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Investigations Weight Decreased	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	16.7% 2/12 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Metabolism and nutrition disorders Decreased Appetite	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	25.0% 3/12 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	16.7% 2/12 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Musculoskeletal and connective tissue disorders Neck Pain	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Nervous system disorders Dysgeusia	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Nervous system disorders Neuropathy Peripheral	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Nervous system disorders Paraesthesia	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	25.0% 3/12 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	16.7% 2/12 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Psychiatric disorders Anxiety	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Reproductive system and breast disorders Breast Pain	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Reproductive system and breast disorders Breast Ulceration	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Reproductive system and breast disorders Metrorrhagia	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	25.0% 3/12 • Number of events 3 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Respiratory, thoracic and mediastinal disorders Pulmonary Toxicity	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Skin and subcutaneous tissue disorders Onychomadesis	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Skin and subcutaneous tissue disorders Pruritus Generalised	9.1% 1/11 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	8.3% 1/12 • Number of events 1 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.
Vascular disorders Hypertension	18.2% 2/11 • Number of events 2 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.	0.00% 0/12 • Adverse event (AE) data was collected from the baseline up to 3 treatment cycles, each cycle 21 days. Reported AEs are TEAEs i.e. AEs that developed/worsened during 'treatment period'(time from the first treatment administration to the last treatment administration + 30 days). Analysis was performed on safety population which included all participants who received at least 1 dose (or any partial dose) of SAR566658.

Additional Information

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