Trial Outcomes & Findings for Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer (NCT NCT01511536)
NCT ID: NCT01511536
Last Updated: 2016-07-28
Results Overview
MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting \>7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Up to Cycle 2 of Phase 1 (up to 42 days)
Results posted on
2016-07-28
Participant Flow
Participants were enrolled at 2 centers in phase 1 part and 3 centers in phase 2 part between March 2012 and April 2014.
Phase I was a dose escalation part of Cabazitaxel, administered with a constant dose of abiraterone, to determine maximally tolerated dose. Phase 2 was efficacy and safety evaluation of Cabazitaxel at a dose, determined in Phase 1, in combination with abiraterone.
Participant milestones
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg
Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|---|---|
|
Phase 1
STARTED
|
3
|
7
|
0
|
|
Phase 1
COMPLETED
|
3
|
6
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
1
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
27
|
|
Phase 2
COMPLETED
|
0
|
0
|
18
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg
Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|---|---|
|
Phase 1
Other
|
0
|
1
|
0
|
|
Phase 2
Other
|
0
|
0
|
9
|
Baseline Characteristics
Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg
n=3 Participants
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
n=7 Participants
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
n=27 Participants
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 2 of Phase 1 (up to 42 days)Population: Analysis was performed on DLT evaluable population defined as all participants who received the first 2 cycles, unless they discontinued the study drug during the first 2 cycles for a DLT.
MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting \>7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.
Outcome measures
| Measure |
Phase 1: Overall Population
n=9 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate
|
25 mg/m^2
|
PRIMARY outcome
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)Population: Analysis was performed on efficacy/activity population included all participants who had received at least 2 cycles of the study drug in Phase 2, and had a baseline and at least one post-baseline assessment for the efficacy variable of interest.
Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response
|
46.2 percentage of participants
Interval 26.6 to 66.6
|
SECONDARY outcome
Timeframe: From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5Population: Analysis was performed on efficacy/activity population.
Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events: 1\) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Objective Progression Free Survival (PFS)
|
NA months
Interval 4.731 to
Data was not calculable as \<50% participants had event of interest.
|
SECONDARY outcome
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)Population: Analysis was performed on efficacy/activity population.
Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA. Analysis was performed by Kaplan Meire method.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: PSA Progression Free Survival
|
6.93 months
Interval 4.14 to 10.251
|
SECONDARY outcome
Timeframe: Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)Population: Efficacy/activity population. Number of participants analyzed=participants with measurable disease at baseline.
Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters).
Outcome measures
| Measure |
Phase 1: Overall Population
n=14 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Percentage of Participants With Objective Response
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
SECONDARY outcome
Timeframe: From baseline up to death or study cut-off (maximum duration: 603 days)Population: Analysis was performed on efficacy/activity population.
Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Overall Survival
|
NA months
Interval 9.429 to
Data was not calculable as \<50% participants had event of interest.
|
SECONDARY outcome
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1Population: Analysis was performed on pharmacokinetic (PK) population which included all participants who received at least 1 treatment. Pre-dose samples from 3 participants of Phase 2, were above lower limit of quantification (LLOQ) (1.00 ng/mL). Hence, those participants were excluded from analysis.
Outcome measures
| Measure |
Phase 1: Overall Population
n=24 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)
|
330 ng/mL
Standard Deviation 187
|
SECONDARY outcome
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1Population: Analysis was performed on PK population.
Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose
Outcome measures
| Measure |
Phase 1: Overall Population
n=24 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)
|
817 ng*h/mL
Standard Deviation 117
|
SECONDARY outcome
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1Population: Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1: Overall Population
n=24 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)
|
91.6 hour
Standard Deviation 62.6
|
SECONDARY outcome
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1Population: Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1: Overall Population
n=24 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)
|
31.4 L/h/m^2
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1Population: Analysis was performed on PK population.
Outcome measures
| Measure |
Phase 1: Overall Population
n=24 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)
|
2711 L/m^2
Standard Deviation 2493
|
SECONDARY outcome
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1Population: Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)
|
216 ng/mL
Standard Deviation 152
|
SECONDARY outcome
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1Population: Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)
|
2.00 hour
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1Population: Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)
|
928 ng*h/mL
Standard Deviation 466
|
SECONDARY outcome
Timeframe: Pre abiraterone dose on Day 1 of Cycle 1Population: Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.
Outcome measures
| Measure |
Phase 1: Overall Population
n=26 Participants
Cabazitaxel 20 or 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|
|
Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)
|
9.99 ng/mL
Standard Deviation 13.0
|
Adverse Events
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
Serious events: 21 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg
n=3 participants at risk
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
n=7 participants at risk
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
n=27 participants at risk
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|---|---|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac failure
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Myocardial ischaemia
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Prostatitis
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Disease progression
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg
n=3 participants at risk
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
n=7 participants at risk
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg
n=27 participants at risk
Cabazitaxel at MTD as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pelvic pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
59.3%
16/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Granuloma
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Blood potassium increased
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Transaminases increased
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
48.1%
13/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Investigations
Weight increased
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
48.1%
13/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
25.9%
7/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
40.7%
11/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
11.1%
3/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
22.2%
6/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
42.9%
3/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
55.6%
15/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
18.5%
5/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Lip pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
71.4%
5/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
51.9%
14/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
18.5%
5/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
22.2%
6/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
18.5%
5/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
33.3%
9/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.8%
4/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
14.3%
1/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
3.7%
1/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
28.6%
2/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
29.6%
8/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
0.00%
0/7 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
7.4%
2/27 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (603 days) regardless of seriousness or relationship to investigational product
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 \[cabazitaxel or abiraterone, whichever came first\] to last dose of study drug \[cabazitaxel or abiraterone, whichever came last\] + 30 days). Analysis was performed on safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER