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Trial record 1 of 1 for:    TED12689
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Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors

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ClinicalTrials.gov Identifier: NCT01751308
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Solid Tumor - Malignant Nervous System Neoplasm
Intervention Drug: Cabazitaxel (XRP6258)
Enrollment 39
Recruitment Details Participants were enrolled at 12 centers between February 2013 and March 2015.
Pre-assignment Details Phase I was a dose escalation part of Cabazitaxel to determine maximum tolerated dose (MTD). Phase 2 was efficacy and safety evaluation of Cabazitaxel at the MTD, determined in Phase 1.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause). Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Period Title: Phase 1
Started 6 3 7 7 0 [1]
Completed 6 [2] 3 [2] 7 [2] 7 [2] 0
Not Completed 0 0 0 0 0
[1]
Phase 1 and Phase 2 were separate populations.
[2]
DP, AE and death were considered as completed (defined in protocol)
Period Title: Phase 2
Started 0 0 0 0 16 [1]
Completed 0 0 0 0 16 [2]
Not Completed 0 0 0 0 0
[1]
Phase 1 and Phase 2 were separate populations.
[2]
DP, AE and death were considered as completed (defined in protocol)
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2 Total
Hide Arm/Group Description Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Total of all reporting groups
Overall Number of Baseline Participants 6 3 7 7 16 39
Hide Baseline Analysis Population Description
All treated (AT)/safety population was defined as all registered participants who actually received at least 1 dose or part of a dose of the investigational medicinal product (IMP).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 7 participants 7 participants 16 participants 39 participants
2-4 years 0 0 2 0 2 4
5-6 years 2 1 0 1 4 8
7-11 years 1 1 3 5 4 14
12-18 years 3 1 2 1 6 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 7 participants 7 participants 16 participants 39 participants
Female
5
  83.3%
0
   0.0%
1
  14.3%
2
  28.6%
8
  50.0%
16
  41.0%
Male
1
  16.7%
3
 100.0%
6
  85.7%
5
  71.4%
8
  50.0%
23
  59.0%
1.Primary Outcome
Title Phase 1: Maximum Tolerated Dose of Cabazitaxel
Hide Description MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases<10* upper limit of normal of ≤7 days, re-treatment delay of>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time Frame Cycle 1 (21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1.
Arm/Group Title Phase 1: Overall Population
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2, 25 mg/m^2, 30 mg/m^2 or 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: mg/m^2
30
2.Primary Outcome
Title Phase 2: Percentage of Participants With Objective Response (OR)
Hide Description OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement.
Time Frame Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description:
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
CR 0
PR 0
3.Primary Outcome
Title Phase 2: Duration of Response (DOR)
Hide Description DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant’s last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume).
Time Frame Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported.
Arm/Group Title Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description:
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel.
Time Frame Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population (AT population).
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 6 3 7 7 16
Measure Type: Number
Unit of Measure: participants
6 3 7 7 16
5.Secondary Outcome
Title Phase 1: Number of Participants With Objective Response
Hide Description OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to <10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement.
Time Frame Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 5 3 7 7
Measure Type: Number
Unit of Measure: participants
1 0 0 0
6.Secondary Outcome
Title Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve
Hide Description Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Time Frame Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1 and 2: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 6 3 20 2
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
669.5  (430.6) 879.0  (414.7) 876.7  (359.9) 1002.5  (277.9)
7.Secondary Outcome
Title Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL)
Hide Description Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Time Frame Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1 and 2: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 6 3 20 2
Mean (Standard Deviation)
Unit of Measure: L/h/m^2
36.05  (12.91) 32.76  (12.72) 38.70  (12.98) 36.61  (9.98)
8.Secondary Outcome
Title Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss)
Hide Description Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Time Frame Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1 and 2: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AEor death (from any cause).
Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 6 3 20 2
Mean (Standard Deviation)
Unit of Measure: L/m^2
3391.72  (686.79) 3301.96  (351.55) 3371.30  (975.98) 1488.75  (1179.11)
9.Secondary Outcome
Title Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax)
Hide Description Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.
Time Frame Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1 and 2: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2
Hide Arm/Group Description:
Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 6 3 20 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
204.864  (189.864) 283.657  (242.970) 256.734  (127.931) 233.290  (0.127)
10.Secondary Outcome
Title Phase 2: Progression Free Survival (PFS)
Hide Description The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method.
Time Frame Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description:
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
1.3
(0.6 to 2.1)
11.Secondary Outcome
Title Phase 2: Overall Survival (OS)
Hide Description OS was defined as the time (in months) from the date of first dose administration until the date of death (from any cause). If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive and the study cut-off date. The analysis was performed by Kaplan-Meier method.
Time Frame Baseline up to death or study cut-off (maximum duration: 12.1 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description:
Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.7 to 4.5)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (112.1 weeks for Phase 1 and 12.1 weeks for Phase 2) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose of study drug to last dose of study drug + 30 days). Analysis was performed on safety population.
 
Arm/Group Title Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2
Hide Arm/Group Description Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
All-Cause Mortality
Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   1/3 (33.33%)   5/7 (71.43%)   3/7 (42.86%)   12/16 (75.00%) 
Blood and lymphatic system disorders           
Febrile neutropenia  1  1/6 (16.67%)  1/3 (33.33%)  1/7 (14.29%)  2/7 (28.57%)  3/16 (18.75%) 
Neutropenia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Cardiac disorders           
Cardiac arrest  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders           
Diarrhoea  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  2/16 (12.50%) 
General disorders           
Death  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Disease progression  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  3/16 (18.75%) 
Fatigue  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Immune system disorders           
Anaphylactic reaction  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  3/16 (18.75%) 
Infections and infestations           
Gastroenteritis  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Neutropenic sepsis  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Stoma site infection  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Upper respiratory tract infection  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Varicella zoster virus infection  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications           
Brain herniation  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Investigations           
Platelet count decreased  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders           
Bone pain  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Intracranial tumour haemorrhage  1  1/6 (16.67%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
Neoplasm progression  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Tumour pain  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Nervous system disorders           
Hydrocephalus  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  1/16 (6.25%) 
Nerve root compression  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Paraesthesia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Renal and urinary disorders           
Cystitis noninfective  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Aspiration  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Dyspnoea  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Hypoventilation  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Pneumonia aspiration  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Vascular disorders           
Hypotension  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1: Cabazitaxel 20 mg/m^2 Phase 1: Cabazitaxel 25 mg/m^2 Phase 1: Cabazitaxel 30 mg/m^2 Phase 1: Cabazitaxel 35 mg/m^2 Phase 2: Cabazitaxel 30 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   3/3 (100.00%)   7/7 (100.00%)   7/7 (100.00%)   15/16 (93.75%) 
Blood and lymphatic system disorders           
Anaemia  1  1/6 (16.67%)  1/3 (33.33%)  2/7 (28.57%)  1/7 (14.29%)  1/16 (6.25%) 
Neutropenia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Cardiac disorders           
Bradycardia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Sinus bradycardia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Sinus tachycardia  1  1/6 (16.67%)  1/3 (33.33%)  1/7 (14.29%)  1/7 (14.29%)  0/16 (0.00%) 
Tachycardia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
Eye disorders           
Cataract  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Eye pain  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Eyelid pain  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Vision blurred  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  0/6 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  3/7 (42.86%)  2/16 (12.50%) 
Abdominal pain upper  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Constipation  1  1/6 (16.67%)  1/3 (33.33%)  2/7 (28.57%)  2/7 (28.57%)  3/16 (18.75%) 
Diarrhoea  1  2/6 (33.33%)  1/3 (33.33%)  4/7 (57.14%)  1/7 (14.29%)  5/16 (31.25%) 
Dry mouth  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Dyspepsia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Dysphagia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  6/16 (37.50%) 
Gastrooesophageal reflux disease  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Glossodynia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Ileus  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Nausea  1  2/6 (33.33%)  1/3 (33.33%)  3/7 (42.86%)  2/7 (28.57%)  5/16 (31.25%) 
Stomatitis  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Vomiting  1  0/6 (0.00%)  2/3 (66.67%)  3/7 (42.86%)  2/7 (28.57%)  4/16 (25.00%) 
General disorders           
Catheter site pain  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Device occlusion  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Fatigue  1  2/6 (33.33%)  1/3 (33.33%)  2/7 (28.57%)  3/7 (42.86%)  3/16 (18.75%) 
Gait disturbance  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Localised oedema  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Malaise  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
Oedema  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Oedema peripheral  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Pain  1  0/6 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  0/7 (0.00%)  0/16 (0.00%) 
Pyrexia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  2/16 (12.50%) 
Immune system disorders           
Hypersensitivity  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
Seasonal allergy  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Infections and infestations           
Candida infection  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
Conjunctivitis  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Enterocolitis bacterial  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Lip infection  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
Mucosal infection  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  2/16 (12.50%) 
Upper respiratory tract infection  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Urinary tract infection  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Varicella zoster virus infection  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications           
Infusion related reaction  1  1/6 (16.67%)  1/3 (33.33%)  0/7 (0.00%)  2/7 (28.57%)  2/16 (12.50%) 
Rectal injury  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Investigations           
Alanine aminotransferase increased  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Candida test positive  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Coronavirus test positive  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Platelet count decreased  1  0/6 (0.00%)  1/3 (33.33%)  2/7 (28.57%)  0/7 (0.00%)  1/16 (6.25%) 
Weight decreased  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
White blood cell count decreased  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Metabolism and nutrition disorders           
Decreased appetite  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/7 (28.57%)  1/16 (6.25%) 
Dehydration  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  1/16 (6.25%) 
Hypokalaemia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Hypomagnesaemia  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Back pain  1  1/6 (16.67%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  2/16 (12.50%) 
Bone pain  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Joint hyperextension  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Muscular weakness  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Myalgia  1  1/6 (16.67%)  1/3 (33.33%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Neck pain  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Pain in extremity  1  1/6 (16.67%)  0/3 (0.00%)  2/7 (28.57%)  0/7 (0.00%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumour pain  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Nervous system disorders           
Accessory nerve disorder  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Ataxia  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  2/7 (28.57%)  2/16 (12.50%) 
Balance disorder  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Cerebellar ataxia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
Cerebellar syndrome  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
Cranial nerve paralysis  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Dizziness  1  0/6 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  2/7 (28.57%)  0/16 (0.00%) 
Dysarthria  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  3/16 (18.75%) 
Facial nerve disorder  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Headache  1  4/6 (66.67%)  1/3 (33.33%)  1/7 (14.29%)  2/7 (28.57%)  4/16 (25.00%) 
Hemiparesis  1  2/6 (33.33%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  3/16 (18.75%) 
Hydrocephalus  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Hypoglossal nerve disorder  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Hypotonia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Lethargy  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
Muscle spasticity  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Paraesthesia  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Peripheral sensory neuropathy  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Seizure  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Somnolence  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
Tremor  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
VIIIth nerve lesion  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
VIth nerve disorder  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
VIth nerve paralysis  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/16 (12.50%) 
Psychiatric disorders           
Agitation  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Anxiety  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Confusional state  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Deja vu  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Insomnia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Renal and urinary disorders           
Dysuria  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Haematuria  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Pollakiuria  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Proteinuria  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Urinary retention  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Reproductive system and breast disorders           
Dysmenorrhoea  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Ovarian cyst  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Aspiration  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Atelectasis  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Cough  1  0/6 (0.00%)  2/3 (66.67%)  3/7 (42.86%)  1/7 (14.29%)  0/16 (0.00%) 
Dysphonia  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Dyspnoea  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Dyspnoea exertional  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Epistaxis  1  0/6 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  1/7 (14.29%)  2/16 (12.50%) 
Hypoxia  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Nasal congestion  1  0/6 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  1/7 (14.29%)  1/16 (6.25%) 
Oropharyngeal pain  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Pneumonitis  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Pulmonary oedema  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Rhinitis allergic  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Rhinorrhoea  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Upper-airway cough syndrome  1  0/6 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Wheezing  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  1/6 (16.67%)  1/3 (33.33%)  1/7 (14.29%)  0/7 (0.00%)  1/16 (6.25%) 
Dry skin  1  1/6 (16.67%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/6 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/16 (0.00%) 
Rash  1  1/6 (16.67%)  0/3 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/16 (0.00%) 
Skin ulcer  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Vascular disorders           
Flushing  1  1/6 (16.67%)  1/3 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  0/16 (0.00%) 
Hypotension  1  0/6 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18.1
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01751308     History of Changes
Other Study ID Numbers: TED12689
U1111-1128-5704 ( Other Identifier: UTN )
First Submitted: December 13, 2012
First Posted: December 17, 2012
Results First Submitted: June 28, 2016
Results First Posted: August 12, 2016
Last Update Posted: August 12, 2016