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Trial record 1 of 1 for:    TED12414
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Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

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ClinicalTrials.gov Identifier: NCT01587040
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasm Malignant
Interventions Drug: SAR245408
Drug: SAR245409
Enrollment 61
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.
Arm/Group Title SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Hide Arm/Group Description Participants received SAR245408 400 milligrams (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). 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). 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). 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).
Period Title: Overall Study
Started 17 3 37 4
Completed 0 0 0 0
Not Completed 17 3 37 4
Reason Not Completed
Protocol Violation             0             0             1             0
Adverse Event             0             1             10             0
Disease progression             12             1             15             3
Other than specified             5             1             11             1
Arm/Group Title SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen Total
Hide Arm/Group Description 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). 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). 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). 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). Total of all reporting groups
Overall Number of Baseline Participants 17 3 37 4 61
Hide Baseline Analysis Population Description
Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 3 participants 37 participants 4 participants 61 participants
61.6  (13.1) 53.7  (2.1) 62.4  (12.0) 50.0  (15.8) 61.0  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 3 participants 37 participants 4 participants 61 participants
Female
12
  70.6%
3
 100.0%
16
  43.2%
0
   0.0%
31
  50.8%
Male
5
  29.4%
0
   0.0%
21
  56.8%
4
 100.0%
30
  49.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 3 participants 37 participants 4 participants 61 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
2
   5.4%
0
   0.0%
3
   4.9%
Not Hispanic or Latino
17
 100.0%
2
  66.7%
35
  94.6%
4
 100.0%
58
  95.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 3 participants 37 participants 4 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  17.6%
0
   0.0%
5
  13.5%
0
   0.0%
8
  13.1%
White
14
  82.4%
2
  66.7%
31
  83.8%
4
 100.0%
51
  83.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
1
   1.6%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study.
Arm/Group Title SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Hide Arm/Group Description:
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).
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).
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).
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).
Overall Number of Participants Analyzed 17 3 37 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
16
  94.1%
3
 100.0%
35
  94.6%
3
  75.0%
Any Grade 3-4 TEAEs
12
  70.6%
2
  66.7%
19
  51.4%
1
  25.0%
Any related TEAEs
12
  70.6%
3
 100.0%
23
  62.2%
2
  50.0%
Any Grade 3-4 related TEAE
3
  17.6%
0
   0.0%
11
  29.7%
0
   0.0%
Any Serious TEAE
9
  52.9%
1
  33.3%
10
  27.0%
0
   0.0%
Any Grade 3-4 TESAE
9
  52.9%
1
  33.3%
9
  24.3%
0
   0.0%
Any related TESAE
2
  11.8%
0
   0.0%
1
   2.7%
0
   0.0%
Any Grade 3-4 related TESAE
2
  11.8%
0
   0.0%
0
   0.0%
0
   0.0%
Any TEAE leading to death
0
   0.0%
0
   0.0%
3
   8.1%
0
   0.0%
Any TEAE leading to permanent discontinuation
1
   5.9%
1
  33.3%
8
  21.6%
0
   0.0%
Any TEAE leading to dose reduction
3
  17.6%
1
  33.3%
9
  24.3%
1
  25.0%
Any TEAE leading to dose delay or interruption
6
  35.3%
2
  66.7%
16
  43.2%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
Arm/Group Title SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Hide Arm/Group Description:
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).
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).
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).
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).
Overall Number of Participants Analyzed 16 3 36 4
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia: All grades
13
  81.3%
1
  33.3%
23
  63.9%
1
  25.0%
Anemia: Grade 1
6
  37.5%
1
  33.3%
18
  50.0%
1
  25.0%
Anemia: Grade 2
3
  18.8%
0
   0.0%
2
   5.6%
0
   0.0%
Anemia: Grade 3
4
  25.0%
0
   0.0%
3
   8.3%
0
   0.0%
Anemia: Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutropenia: All grades
7
  43.8%
0
   0.0%
10
  27.8%
1
  25.0%
Neutropenia: Grade 1
2
  12.5%
0
   0.0%
5
  13.9%
1
  25.0%
Neutropenia: Grade 2
2
  12.5%
0
   0.0%
1
   2.8%
0
   0.0%
Neutropenia: Grade 3
2
  12.5%
0
   0.0%
2
   5.6%
0
   0.0%
Neutropenia: Grade 4
1
   6.3%
0
   0.0%
2
   5.6%
0
   0.0%
Thrombocytopenia: All grades
8
  50.0%
0
   0.0%
20
  55.6%
3
  75.0%
Thrombocytopenia: Grade 1
5
  31.3%
0
   0.0%
17
  47.2%
3
  75.0%
Thrombocytopenia: Grade 2
0
   0.0%
0
   0.0%
2
   5.6%
0
   0.0%
Thrombocytopenia: Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Thrombocytopenia: Grade 4
3
  18.8%
0
   0.0%
1
   2.8%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population. Here, "number analyzed"= participants with available data for specified category.
Arm/Group Title SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Hide Arm/Group Description:
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).
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).
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).
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).
Overall Number of Participants Analyzed 17 3 37 4
Measure Type: Count of Participants
Unit of Measure: Participants
Hyperglycemia: All Grades Number Analyzed 16 participants 3 participants 36 participants 4 participants
13
  81.3%
3
 100.0%
25
  69.4%
1
  25.0%
Hyperglycemia: Grade 1 Number Analyzed 16 participants 3 participants 36 participants 4 participants
11
  68.8%
2
  66.7%
19
  52.8%
1
  25.0%
Hyperglycemia: Grade 2 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
1
  33.3%
6
  16.7%
0
   0.0%
Hyperglycemia: Grade 3 Number Analyzed 16 participants 3 participants 36 participants 4 participants
2
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperglycemia: Grade 4 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASAT Increased: All Grades Number Analyzed 16 participants 3 participants 36 participants 4 participants
7
  43.8%
2
  66.7%
20
  55.6%
1
  25.0%
ASAT Increased: Grade 1 Number Analyzed 16 participants 3 participants 36 participants 4 participants
6
  37.5%
1
  33.3%
16
  44.4%
1
  25.0%
ASAT Increased: Grade 2 Number Analyzed 16 participants 3 participants 36 participants 4 participants
1
   6.3%
1
  33.3%
2
   5.6%
0
   0.0%
ASAT Increased: Grade 3 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
2
   5.6%
0
   0.0%
ASAT Increased: Grade 4 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALAT Increased: All Grades Number Analyzed 16 participants 3 participants 36 participants 4 participants
5
  31.3%
2
  66.7%
12
  33.3%
0
   0.0%
ALAT Increased: Grade 1 Number Analyzed 16 participants 3 participants 36 participants 4 participants
4
  25.0%
1
  33.3%
8
  22.2%
0
   0.0%
ALAT Increased: Grade 2 Number Analyzed 16 participants 3 participants 36 participants 4 participants
1
   6.3%
1
  33.3%
1
   2.8%
0
   0.0%
ALAT Increased: Grade 3 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
3
   8.3%
0
   0.0%
ALAT Increased: Grade 4 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Blood Bilirubin Increased:All Grades Number Analyzed 15 participants 3 participants 36 participants 4 participants
1
   6.7%
0
   0.0%
9
  25.0%
1
  25.0%
Blood Bilirubin Increased:Grade 1 Number Analyzed 15 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
4
  11.1%
1
  25.0%
Blood Bilirubin Increased:Grade 2 Number Analyzed 15 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
3
   8.3%
0
   0.0%
Blood Bilirubin Increased:Grade 3 Number Analyzed 15 participants 3 participants 36 participants 4 participants
1
   6.7%
0
   0.0%
2
   5.6%
0
   0.0%
Blood Bilirubin Increased:Grade 4 Number Analyzed 15 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia: All Grades Number Analyzed 16 participants 3 participants 36 participants 4 participants
6
  37.5%
1
  33.3%
7
  19.4%
0
   0.0%
Hypocalcemia: Grade 1 Number Analyzed 16 participants 3 participants 36 participants 4 participants
4
  25.0%
1
  33.3%
5
  13.9%
0
   0.0%
Hypocalcemia: Grade 2 Number Analyzed 16 participants 3 participants 36 participants 4 participants
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
Hypocalcemia: Grade 3 Number Analyzed 16 participants 3 participants 36 participants 4 participants
1
   6.3%
0
   0.0%
2
   5.6%
0
   0.0%
Hypocalcemia: Grade 4 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine increased: All Grades Number Analyzed 16 participants 3 participants 36 participants 4 participants
5
  31.3%
1
  33.3%
15
  41.7%
0
   0.0%
Creatinine increased: Grade 1 Number Analyzed 16 participants 3 participants 36 participants 4 participants
3
  18.8%
1
  33.3%
8
  22.2%
0
   0.0%
Creatinine increased: Grade 2 Number Analyzed 16 participants 3 participants 36 participants 4 participants
1
   6.3%
0
   0.0%
4
  11.1%
0
   0.0%
Creatinine increased: Grade 3 Number Analyzed 16 participants 3 participants 36 participants 4 participants
0
   0.0%
0
   0.0%
2
   5.6%
0
   0.0%
Creatinine increased: Grade 4 Number Analyzed 16 participants 3 participants 36 participants 4 participants
1
   6.3%
0
   0.0%
1
   2.8%
0
   0.0%
Time Frame All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the ‘on treatment period’ (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
 
Arm/Group Title SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Hide Arm/Group Description 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). 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). 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). 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).
All-Cause Mortality
SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/17 (5.88%)      0/3 (0.00%)      3/37 (8.11%)      0/4 (0.00%)    
Hide Serious Adverse Events
SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/17 (52.94%)      1/3 (33.33%)      10/37 (27.03%)      0/4 (0.00%)    
Blood and lymphatic system disorders         
Anaemia  1  2/17 (11.76%)  2 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Neutropenia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Thrombocytopenia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Cardiac disorders         
Angina Unstable  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders         
Constipation  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Gastritis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Intestinal Obstruction  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Upper Gastrointestinal Haemorrhage  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
General disorders         
Disease Progression  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Pyrexia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Systemic Inflammatory Response Syndrome  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hepatobiliary disorders         
Cholangitis Acute  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Cholecystitis Acute  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Infections and infestations         
Abscess Limb  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Acute Sinusitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Catheter Site Infection  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Cellulitis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Intervertebral Discitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Osteomyelitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pneumonia  1  2/17 (11.76%)  2 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Sepsis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Staphylococcal Skin Infection  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Urinary Tract Infection  1  1/17 (5.88%)  1 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Wound Infection  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Injury, poisoning and procedural complications         
Femur Fracture  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Investigations         
Alanine Aminotransferase Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Lipase Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Troponin Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Metabolism and nutrition disorders         
Hypercalcaemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Tumour Lysis Syndrome  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute Leukaemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Acute Myeloid Leukaemia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders         
Encephalopathy  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Haemorrhage Intracranial  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Headache  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Syncope  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Renal and urinary disorders         
Acute Kidney Injury  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Renal Colic  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmonary Disease  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Dyspnoea  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Pleural Effusion  1  2/17 (11.76%)  2 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Respiratory Distress  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders         
Haematoma  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Hypotension  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SAR245408: Monotherapy SAR245408: Combination Regimen SAR245409: Monotherapy SAR245409: Combination Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/17 (88.24%)      3/3 (100.00%)      34/37 (91.89%)      3/4 (75.00%)    
Blood and lymphatic system disorders         
Anaemia  1  3/17 (17.65%)  4 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Iron Deficiency Anaemia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Leukocytosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Leukopenia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Lymphopenia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 1/4 (25.00%)  1
Neutropenia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Splenomegaly  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Thrombocytopenia  1  2/17 (11.76%)  3 0/3 (0.00%)  0 0/37 (0.00%)  0 1/4 (25.00%)  1
Cardiac disorders         
Bradycardia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Cardiac Arrest  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Cardiomegaly  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Coronary Artery Disease  1  2/17 (11.76%)  2 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Pericardial Effusion  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Sinus Bradycardia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Tachycardia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Ventricular Extrasystoles  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Ventricular Tachycardia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Ear and labyrinth disorders         
Cerumen Impaction  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Deafness Unilateral  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Ear Discomfort  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hyperacusis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypoacusis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Tinnitus  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Vertigo  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Endocrine disorders         
Hyperthyroidism  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypothyroidism  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Eye disorders         
Cataract  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Corneal Scar  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Dry Eye  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Retinal Vein Occlusion  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Visual Impairment  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Vitreous Floaters  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Gastrointestinal disorders         
Abdominal Distension  1  1/17 (5.88%)  1 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Abdominal Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Abdominal Pain Lower  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Abdominal Tenderness  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Abdominal Wall Haematoma  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Anal Incontinence  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Ascites  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Chapped Lips  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Constipation  1  4/17 (23.53%)  4 1/3 (33.33%)  1 7/37 (18.92%)  7 1/4 (25.00%)  1
Diarrhoea  1  7/17 (41.18%)  8 2/3 (66.67%)  2 14/37 (37.84%)  14 3/4 (75.00%)  3
Dyspepsia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Dysphagia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Faeces Discoloured  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Flatulence  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Gastrooesophageal Reflux Disease  1  3/17 (17.65%)  4 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Hypoaesthesia Oral  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Nausea  1  5/17 (29.41%)  5 2/3 (66.67%)  2 10/37 (27.03%)  10 0/4 (0.00%)  0
Pancreatic Failure  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Peptic Ulcer Haemorrhage  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Salivary Gland Enlargement  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Short-Bowel Syndrome  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Vomiting  1  2/17 (11.76%)  2 2/3 (66.67%)  2 7/37 (18.92%)  7 1/4 (25.00%)  1
General disorders         
Asthenia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Catheter Site Discharge  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Chest Pain  1  0/17 (0.00%)  0 1/3 (33.33%)  1 1/37 (2.70%)  1 0/4 (0.00%)  0
Chills  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Face Oedema  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Facial Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 0/37 (0.00%)  0 1/4 (25.00%)  1
Fatigue  1  8/17 (47.06%)  9 1/3 (33.33%)  1 8/37 (21.62%)  8 0/4 (0.00%)  0
Gait Disturbance  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
General Physical Health Deterioration  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Localised Oedema  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Malaise  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Mucosal Inflammation  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Non-Cardiac Chest Pain  1  1/17 (5.88%)  1 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Oedema Peripheral  1  3/17 (17.65%)  3 1/3 (33.33%)  1 4/37 (10.81%)  4 0/4 (0.00%)  0
Pain  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Performance Status Decreased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Peripheral Swelling  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pyrexia  1  4/17 (23.53%)  4 1/3 (33.33%)  1 6/37 (16.22%)  6 0/4 (0.00%)  0
Suprapubic Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Immune system disorders         
Contrast Media Allergy  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Drug Hypersensitivity  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Hypersensitivity  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations         
Abscess Limb  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Bronchitis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 4/37 (10.81%)  5 0/4 (0.00%)  0
Cellulitis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Chronic Sinusitis  1  2/17 (11.76%)  2 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Conjunctivitis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Eye Infection  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Fungal Skin Infection  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Gastroenteritis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Gastrointestinal Viral Infection  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hepatitis C  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Herpes Zoster  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Hordeolum  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Influenza  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Lower Respiratory Tract Infection  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Nasopharyngitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Onychomycosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Oral Candidiasis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Pneumonia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Postoperative Wound Infection  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Respiratory Tract Infection  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Rhinitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Sepsis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Sinusitis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 5/37 (13.51%)  5 1/4 (25.00%)  1
Skin Infection  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Tooth Abscess  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Tooth Infection  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 1/4 (25.00%)  1
Upper Respiratory Tract Infection  1  3/17 (17.65%)  3 0/3 (0.00%)  0 8/37 (21.62%)  8 1/4 (25.00%)  1
Urinary Tract Infection  1  2/17 (11.76%)  2 1/3 (33.33%)  1 6/37 (16.22%)  6 0/4 (0.00%)  0
Viral Upper Respiratory Tract Infection  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Injury, poisoning and procedural complications         
Accidental Overdose  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Contusion  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Fall  1  2/17 (11.76%)  2 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Foreign Body In Eye  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Incision Site Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Ligament Injury  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Limb Injury  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Muscle Strain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Rib Fracture  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Skin Abrasion  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Spinal Compression Fracture  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Wound Dehiscence  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Investigations         
Activated Partial Thromboplastin Time Prolonged  1  1/17 (5.88%)  3 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Alanine Aminotransferase Increased  1  0/17 (0.00%)  0 2/3 (66.67%)  2 4/37 (10.81%)  5 0/4 (0.00%)  0
Amylase Increased  1  1/17 (5.88%)  1 0/3 (0.00%)  0 6/37 (16.22%)  6 0/4 (0.00%)  0
Aspartate Aminotransferase Increased  1  0/17 (0.00%)  0 2/3 (66.67%)  2 3/37 (8.11%)  3 0/4 (0.00%)  0
Bilirubin Conjugated Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Blood Alkaline Phosphatase Increased  1  0/17 (0.00%)  0 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Blood Bilirubin Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Blood Cholesterol Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Blood Creatinine Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Blood Lactate Dehydrogenase Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Blood Phosphorus Decreased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Blood Urea Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Body Temperature Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Breath Sounds Abnormal  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Breath Sounds Absent  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Cardiac Murmur  1  2/17 (11.76%)  2 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Chest X-Ray Abnormal  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Electrocardiogram Qt Prolonged  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Heart Rate Irregular  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
International Normalised Ratio Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Lipase Increased  1  2/17 (11.76%)  2 0/3 (0.00%)  0 8/37 (21.62%)  8 0/4 (0.00%)  0
Neutrophil Count Decreased  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Nuclear Magnetic Resonance Imaging Brain Abnormal  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Platelet Count Decreased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Procalcitonin Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Protein Urine Present  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Prothrombin Time Prolonged  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Red Blood Cell Count Decreased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Red Blood Cells Urine  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Urine Analysis Abnormal  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Urine Protein/Creatinine Ratio Increased  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Vitamin B12 Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Vitamin D Decreased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Weight Decreased  1  1/17 (5.88%)  1 0/3 (0.00%)  0 4/37 (10.81%)  4 0/4 (0.00%)  0
Weight Increased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
White Blood Cell Count Decreased  1  1/17 (5.88%)  2 1/3 (33.33%)  1 1/37 (2.70%)  1 0/4 (0.00%)  0
White Blood Cell Count Increased  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
White Blood Cells Urine  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
White Blood Cells Urine Positive  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders         
Acidosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Decreased Appetite  1  2/17 (11.76%)  2 1/3 (33.33%)  1 5/37 (13.51%)  5 0/4 (0.00%)  0
Dehydration  1  2/17 (11.76%)  2 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Diabetes Mellitus  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Gout  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypercalcaemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypercholesterolaemia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hyperglycaemia  1  1/17 (5.88%)  1 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Hyperkalaemia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hyperlipidaemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hyperphosphataemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypoalbuminaemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Hypocalcaemia  1  1/17 (5.88%)  1 1/3 (33.33%)  1 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypokalaemia  1  1/17 (5.88%)  1 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Hypomagnesaemia  1  3/17 (17.65%)  3 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hyponatraemia  1  2/17 (11.76%)  3 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Hypophosphataemia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Metabolic Acidosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Vitamin D Deficiency  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Back Pain  1  4/17 (23.53%)  4 1/3 (33.33%)  1 4/37 (10.81%)  4 0/4 (0.00%)  0
Bursitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Flank Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Groin Pain  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Joint Swelling  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Muscle Spasms  1  3/17 (17.65%)  3 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Muscle Twitching  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Muscular Weakness  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Musculoskeletal Chest Pain  1  0/17 (0.00%)  0 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Musculoskeletal Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Myalgia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Neck Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Osteoarthritis  1  2/17 (11.76%)  2 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Osteoporosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pain In Extremity  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pain In Jaw  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pathological Fracture  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Periarthritis  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Pubic Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Scoliosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal Cell Carcinoma  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Squamous Cell Carcinoma Of Skin  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Tumour Pain  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Nervous system disorders         
Amnesia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Aphasia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Ataxia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Cognitive Disorder  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Dizziness  1  3/17 (17.65%)  3 0/3 (0.00%)  0 2/37 (5.41%)  2 1/4 (25.00%)  1
Dizziness Postural  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Dysarthria  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Headache  1  1/17 (5.88%)  1 0/3 (0.00%)  0 6/37 (16.22%)  6 0/4 (0.00%)  0
Hypoaesthesia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Lethargy  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Memory Impairment  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Neuropathy Peripheral  1  2/17 (11.76%)  2 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Paraesthesia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Partial Seizures  1  0/17 (0.00%)  0 0/3 (0.00%)  0 0/37 (0.00%)  0 1/4 (25.00%)  1
Peripheral Sensory Neuropathy  1  0/17 (0.00%)  0 2/3 (66.67%)  2 2/37 (5.41%)  2 0/4 (0.00%)  0
Sciatica  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Seizure  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Syncope  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Tremor  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Visual Field Defect  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Product Issues         
Thrombosis In Device  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Psychiatric disorders         
Anxiety  1  4/17 (23.53%)  4 0/3 (0.00%)  0 4/37 (10.81%)  4 0/4 (0.00%)  0
Confusional State  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Depression  1  2/17 (11.76%)  2 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Emotional Distress  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hallucination  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Insomnia  1  2/17 (11.76%)  2 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Post-Traumatic Stress Disorder  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Renal and urinary disorders         
Chronic Kidney Disease  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Dysuria  1  0/17 (0.00%)  0 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Glycosuria  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Haematuria  1  1/17 (5.88%)  1 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Haemoglobinuria  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Hydronephrosis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Micturition Urgency  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Nephrolithiasis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Nocturia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Oliguria  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pollakiuria  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Proteinuria  1  1/17 (5.88%)  1 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Renal Failure  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Urinary Hesitation  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Urinary Incontinence  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Urinary Retention  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Urinary Tract Pain  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Urine Flow Decreased  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Reproductive system and breast disorders         
Benign Prostatic Hyperplasia  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Prostatic Obstruction  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Testicular Swelling  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Atelectasis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Cough  1  0/17 (0.00%)  0 2/3 (66.67%)  2 8/37 (21.62%)  8 0/4 (0.00%)  0
Dysphonia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Dyspnoea  1  3/17 (17.65%)  3 1/3 (33.33%)  1 3/37 (8.11%)  3 0/4 (0.00%)  0
Dyspnoea Exertional  1  1/17 (5.88%)  1 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Hypoxia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Nasal Congestion  1  0/17 (0.00%)  0 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Oropharyngeal Pain  1  1/17 (5.88%)  3 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Paranasal Sinus Discomfort  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pleural Effusion  1  1/17 (5.88%)  1 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Pneumonitis  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Productive Cough  1  0/17 (0.00%)  0 0/3 (0.00%)  0 4/37 (10.81%)  4 0/4 (0.00%)  0
Rhinitis Allergic  1  1/17 (5.88%)  1 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Rhinorrhoea  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Sleep Apnoea Syndrome  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Tachypnoea  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Tonsillar Inflammation  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Wheezing  1  1/17 (5.88%)  1 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders         
Actinic Keratosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Alopecia  1  0/17 (0.00%)  0 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Blister  1  1/17 (5.88%)  1 1/3 (33.33%)  1 1/37 (2.70%)  1 0/4 (0.00%)  0
Decubitus Ulcer  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Dermatitis Acneiform  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Dry Skin  1  1/17 (5.88%)  1 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Erythema  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Hyperhidrosis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Ingrowing Nail  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  2 0/4 (0.00%)  0
Nail Pigmentation  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Night Sweats  1  1/17 (5.88%)  2 0/3 (0.00%)  0 3/37 (8.11%)  3 0/4 (0.00%)  0
Onychoclasis  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Pain Of Skin  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Palmar-Plantar Erythrodysaesthesia Syndrome  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Petechiae  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Photosensitivity Reaction  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Precancerous Skin Lesion  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Pruritus  1  1/17 (5.88%)  1 2/3 (66.67%)  2 2/37 (5.41%)  2 0/4 (0.00%)  0
Pruritus Generalised  1  1/17 (5.88%)  1 1/3 (33.33%)  1 2/37 (5.41%)  2 0/4 (0.00%)  0
Psoriasis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Rash  1  0/17 (0.00%)  0 1/3 (33.33%)  1 1/37 (2.70%)  1 0/4 (0.00%)  0
Rash Generalised  1  1/17 (5.88%)  1 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Rash Macular  1  2/17 (11.76%)  2 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Rash Maculo-Papular  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Rash Pruritic  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Scab  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Seborrhoeic Dermatitis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Skin Hyperpigmentation  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Skin Lesion  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Skin Mass  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Swelling Face  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Urticaria  1  1/17 (5.88%)  1 0/3 (0.00%)  0 0/37 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders         
Brachiocephalic Vein Thrombosis  1  0/17 (0.00%)  0 1/3 (33.33%)  1 0/37 (0.00%)  0 0/4 (0.00%)  0
Deep Vein Thrombosis  1  0/17 (0.00%)  0 0/3 (0.00%)  0 2/37 (5.41%)  2 0/4 (0.00%)  0
Flushing  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hot Flush  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Hypertension  1  5/17 (29.41%)  5 1/3 (33.33%)  1 8/37 (21.62%)  8 0/4 (0.00%)  0
Hypotension  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Lymphoedema  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
Systolic Hypertension  1  0/17 (0.00%)  0 0/3 (0.00%)  0 1/37 (2.70%)  1 0/4 (0.00%)  0
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01587040    
Other Study ID Numbers: TED12414
2011-006140-78 ( EudraCT Number )
U1111-1124-1403 ( Other Identifier: UTN )
First Submitted: April 25, 2012
First Posted: April 27, 2012
Results First Submitted: May 21, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019