Neoplasm Malignant
Conditions
Brief summary
Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.
Detailed description
The duration of the study for an individual participant included: 1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal product (IMP). 2. Study treatment period(s): Participants started study treatment at the beginning of the initiation or extension periods based on the length of prior therapy with SAR245408 or SAR245409 * if \<2 cycles, started with initiation period; Participant must have had completed all the visits in the initiation period before moving to the extension period. * if \>=2 cycles, started with extension period; duration of extension period was unlimited. * Participants who took a SAR245408 or SAR245409 daily dose higher than their established dose of SAR245408 or SAR245409, respectively, in the parental study entered the study on Day 1 of the initiation period. * Participants who had dose interrupted in the parental study but fulfilled parental protocol criteria to restart IMP treatment entered the treatment-extension study on Day 1 of the initiation period. * Participants who fulfilled the parental study criteria for IMP treatment continuation but had ongoing Grade 2 adverse events (AEs) entered the treatment-extension study on Day 1 of the initiation period. Participants continued to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 or SAR245409 were available to them outside of the clinical trial. 3. Follow-up assessments: 23 to 37 days after the last dose of IMP.
Interventions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
: I 01. Males or females enrolled in Phase 1 or Phase 2 studies of SAR245408 or SAR245409 as monotherapy or in combination with other regimens who had completed data collection for the primary endpoint(s) of the parental study or who were being treated beyond the parental study cut-off and meet all the criteria to continue to be treated per the parental protocol. I 02. All sexually active participants (male and female) must agreed to continue to use accepted methods of barrier contraception (i.e., condoms) during the course of the study and for 3 months after discontinuation of study treatment. For women of childbearing potential and for men who could father a child, a second method of contraception in addition to a barrier method is recommended. Hormonal contraception should be avoided in participants taking SAR245408 due to possible drug-drug interaction. I 03. Female participants of childbearing potential must had a negative pregnancy test at baseline. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
Exclusion criteria
E 01. The participant discontinued the parental study due to toxicity. E 02. Ongoing Grade 3 or higher Adverse Event (AE). E 03. Ongoing Serious Adverse Event (SAE). E 04. Participants with ongoing dose interruption for any reason unless the participant fulfilled the criteria in the parental protocol for restarting IMP. In such case participant started the treatment-extension study on Day 1 of the initiation period. E 05. The participant had any of the following laboratory values ≥ Common Terminology of Adverse Events (CTCAE) Grade 3 * Absolute neutrophil count (ANC), * Platelet count, * Hemoglobin, * Bilirubin, * Serum creatinine or calculated creatinine clearance, * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), * Fasting plasma glucose (FPG), * Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT). E 06. The participant had a baseline corrected QT interval (QTc) \>481 millisecond (msec) or if a participant has had a QTc interval increase of ≥ 60 msec from parental protocol baseline to an absolute value of \> 470 msec. E 07. The participant had a known allergy or hypersensitivity to components of the study treatment formulation(s). E 08. The participant was pregnant or breastfeeding. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE & non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation & AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs. |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
Countries
Belgium, France, Spain, United States
Participant flow
Recruitment details
The study was conducted at 21 centers in 4 countries between 20 July 2012 and 23 May 2018. Participants who received SAR245408/SAR245409 (IMP) in parental studies (TED12471 \[NCT01596270\], ARD11437 \[NCT01082068\], TED12863 \[NCT01943838\]) were included in study. A total of 67 participants were screened and 61 participants were enrolled in this study.
Pre-assignment details
Participants who received IMP for \<2 cycles in parental study, and participants who took a daily dose of IMP higher than their established dose entered treatment-extension study on Day 1 of initiation period; participants who received IMP \>=2 cycles in parental study entered treatment-extension study on Day 1 of extension period.
Participants by arm
| Arm | Count |
|---|---|
| SAR245408: Monotherapy Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). | 17 |
| SAR245408: Combination Regimen Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab). | 3 |
| SAR245409: Monotherapy Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). | 37 |
| SAR245409: Combination Regimen Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab). | 4 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 10 | 0 |
| Overall Study | Disease progression | 12 | 1 | 15 | 3 |
| Overall Study | Other than specified | 5 | 1 | 11 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | SAR245408: Monotherapy | SAR245408: Combination Regimen | SAR245409: Monotherapy | SAR245409: Combination Regimen | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 13.1 | 53.7 years STANDARD_DEVIATION 2.1 | 62.4 years STANDARD_DEVIATION 12 | 50.0 years STANDARD_DEVIATION 15.8 | 61.0 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 2 Participants | 35 Participants | 4 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 2 Participants | 31 Participants | 4 Participants | 51 Participants |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 16 Participants | 0 Participants | 31 Participants |
| Sex: Female, Male Male | 5 Participants | 0 Participants | 21 Participants | 4 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 17 | 0 / 3 | 3 / 37 | 0 / 4 |
| other Total, other adverse events | 15 / 17 | 3 / 3 | 34 / 37 | 3 / 4 |
| serious Total, serious adverse events | 9 / 17 | 1 / 3 | 10 / 37 | 0 / 4 |
Outcome results
Primary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Time frame: From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)
Population: Analysis was performed on safety population. Here, number analyzed= participants with available data for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 1 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:All Grades | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 3 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 3 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 4 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 3 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 4 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: All Grades | 5 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 2 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 1 | 4 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: All Grades | 5 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 4 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 3 | 2 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 1 | 11 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 3 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: All Grades | 13 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 4 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 4 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 2 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 1 | 4 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: All Grades | 7 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 2 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: All Grades | 6 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 4 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 1 | 6 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 1 | 3 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 3 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 2 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 2 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: All Grades | 3 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 1 | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 2 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: All Grades | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 1 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 2 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: All Grades | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 1 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 2 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:All Grades | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 1 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: All Grades | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 1 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: All Grades | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 1 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 2 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 2 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 3 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 4 | 1 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 3 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 2 | 4 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 3 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 1 | 19 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 2 | 6 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: All Grades | 20 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: All Grades | 12 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 2 | 3 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: All Grades | 7 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: All Grades | 15 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 1 | 8 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:All Grades | 9 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 1 | 16 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 2 | 1 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 1 | 4 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 1 | 5 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 3 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 3 | 3 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 3 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: All Grades | 25 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 1 | 8 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:All Grades | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 1 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 1 | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 1 | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: All Grades | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Blood Bilirubin Increased:Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: All Grades | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: All Grades | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 1 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hypocalcemia: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: All Grades | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 1 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Creatinine increased: All Grades | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | Hyperglycemia: Grade 1 | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ALAT Increased: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | ASAT Increased: Grade 2 | 0 Participants |
Primary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Time frame: From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)
Population: Analysis was performed on safety population. Here, Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: All grades | 13 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 1 | 5 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 3 | 2 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 2 | 3 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 4 | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: All grades | 8 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 3 | 4 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 1 | 6 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 3 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 4 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: All grades | 7 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 2 | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 1 | 2 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 4 | 3 Participants |
| SAR245408: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 2 | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 1 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 1 | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: All grades | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 2 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 1 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 4 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: All grades | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 3 | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: All grades | 1 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 2 | 1 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: All grades | 23 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 1 | 18 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 2 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 3 | 3 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 4 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: All grades | 10 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 1 | 5 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 3 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 4 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: All grades | 20 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 1 | 17 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 2 | 2 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 3 | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 4 | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 1 | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 1 | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 1 | 3 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: All grades | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: All grades | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Anemia: Grade 2 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 4 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: Grade 3 | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Thrombocytopenia: All grades | 3 Participants |
| SAR245409: Combination Regimen | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | Neutropenia: Grade 2 | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE & non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation & AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.
Time frame: From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)
Population: Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 1 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose delay or interruption | 6 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TESAE | 2 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE | 16 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TEAEs | 12 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TEAE | 3 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TEAEs | 12 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose reduction | 3 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Serious TEAE | 9 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TESAE | 9 Participants |
| SAR245408: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TESAE | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TEAEs | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TESAE | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TEAE | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TESAE | 0 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE | 3 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TESAE | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Serious TEAE | 1 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TEAEs | 3 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose delay or interruption | 2 Participants |
| SAR245408: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose reduction | 1 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TESAE | 0 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE | 35 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TEAEs | 19 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TEAEs | 23 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TEAE | 11 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Serious TEAE | 10 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TESAE | 9 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TESAE | 1 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 3 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 8 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose reduction | 9 Participants |
| SAR245409: Monotherapy | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose delay or interruption | 16 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TESAE | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Serious TEAE | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE | 3 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to permanent discontinuation | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TEAE | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TEAEs | 2 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose delay or interruption | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to dose reduction | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 related TESAE | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any related TESAE | 0 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-4 TEAEs | 1 Participants |
| SAR245409: Combination Regimen | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE leading to death | 0 Participants |