Trial Outcomes & Findings for Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC) (NCT NCT02903160)
NCT ID: NCT02903160
Last Updated: 2024-02-07
Results Overview
Time to disease progression, as determined by either PSA or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC. Time to progression (TTP) is defined as beginning with the time the first dose of PCD regimen is administered until disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
47.8 months
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
Intensive, Non-Cross Reactive Therapy
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Intensive, Non-Cross Reactive Therapy
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Medical Insurance Barriers
|
1
|
Baseline Characteristics
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
Baseline characteristics by cohort
| Measure |
Intensive, Non-Cross Reactive Therapy
n=40 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Amerian Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Gleason score
<=6
|
5 Participants
n=5 Participants
|
|
Gleason score
7
|
10 Participants
n=5 Participants
|
|
Gleason score
>=8
|
21 Participants
n=5 Participants
|
|
Gleason score
Unknown
|
4 Participants
n=5 Participants
|
|
Prostate-specific antigen (PSA)
|
9.6 ng/mL
n=5 Participants
|
|
Alkaline phosphatase
|
98 IU/L
n=5 Participants
|
|
Alkaline phosphatase
Elevated (>126 IU/L)
|
13 Participants
n=5 Participants
|
|
Alkaline phosphatase
Normal (<=126 IU/L)
|
27 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
0
|
27 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
1
|
10 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
unknown
|
3 Participants
n=5 Participants
|
|
Sites of metastasis
Bone
|
29 Participants
n=5 Participants
|
|
Sites of metastasis
Lymph node
|
13 Participants
n=5 Participants
|
|
Sites of metastasis
Lung
|
1 Participants
n=5 Participants
|
|
Sites of metastasis
Liver
|
0 Participants
n=5 Participants
|
|
Sites of metastasis
Other
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 47.8 monthsTime to disease progression, as determined by either PSA or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC. Time to progression (TTP) is defined as beginning with the time the first dose of PCD regimen is administered until disease progression.
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Time to Disease Progression
|
15.2 weeks
Interval 10.8 to 23.2
|
SECONDARY outcome
Timeframe: 47.8 monthsOverall survival defined as the time of study entry to death from any cause.
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Overall Survival (OS)
|
NA weeks
Median OS not reached. Not enough events that have occurred to have a median OS. Not enough event data to estimate the lower and the upper bound of the 95% CI for median OS.
|
SECONDARY outcome
Timeframe: 40 monthsOverall rate of survival at 40 months. Overall rate of Survival as defined by likelihood that a participant on the study is still alive at 40 months follow up
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Overall Rate of Survival
|
63 percent
Interval 47.0 to 85.0
|
SECONDARY outcome
Timeframe: up to 36 weeksPSA response rate - \>90% decrease in PSA compared to baseline
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Number of Participants With PSA Response Rate >90%
after module 1, 12 weeks
|
11 Participants
|
|
Number of Participants With PSA Response Rate >90%
after module 2, 24 weeks
|
14 Participants
|
|
Number of Participants With PSA Response Rate >90%
after module 3, 36 weeks
|
20 Participants
|
SECONDARY outcome
Timeframe: up to 36 weeksNumber of participants with PSA response rate \>=50% decrease in PSA compared to baseline
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Number of Participants With PSA Response Rate >=50%
after module 1, 12 weeks
|
27 Participants
|
|
Number of Participants With PSA Response Rate >=50%
after module 2, 24 weeks
|
28 Participants
|
|
Number of Participants With PSA Response Rate >=50%
after module 3, 36 weeks
|
32 Participants
|
SECONDARY outcome
Timeframe: up to 36 weeksPSA changes was reported globally using a waterfall plot for each module. In participants who have a decline in PSA value from baseline, progression is defined by: * An increase in PSA by 25% above the nadir, AND * An increase in PSA by a minimum of 2 ng/ml, or an increase in PSA to the pre-treatment PSA value, AND * Confirmation by a second PSA at least 3 weeks apart, AND * Occur following at least 12 weeks of therapy, AND * There is no objective evidence of disease response. In participants whose PSA value from baseline has not declined from baseline, progression is defined by: * An increase in PSA by 25% above either the pre-treatment level, or the nadir PSA level (whichever is lowest), AND * An increase in PSA by a minimum of 2 ng/ml, AND * Confirmation by a second PSA at least 3 weeks apart, AND * Occur following at least 12 weeks of therapy, AND * There is no objective evidence of disease response.
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Number of Participants With PSA Progression Compared to Baseline.
after module 1, 12 weeks
|
4 Participants
|
|
Number of Participants With PSA Progression Compared to Baseline.
after module 2, 24 weeks
|
4 Participants
|
|
Number of Participants With PSA Progression Compared to Baseline.
after module 3, 36 weeks
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 36 weeksParticipants with a 50% PSA decline from their baseline PSA level will be considered responders, provided objective tumor measurements are stable or also demonstrate response. Participants with a 25% PSA increase from their baseline PSA will be considered nonresponders. Participants that do not meet criteria for responder or nonresponder, will be considered to have stable disease.
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Number of Participants With Stable PSA as Compared to Baseline
after module 1, 12 weeks
|
2 Participants
|
|
Number of Participants With Stable PSA as Compared to Baseline
after module 2, 24 weeks
|
1 Participants
|
|
Number of Participants With Stable PSA as Compared to Baseline
after module 3, 36 weeks
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline and 36 weeksPopulation: Data for those with elevated alkaline phosphatase levels at baseline and with results available at 36 weeks
Number of participants who converted from elevated to normal range of alkaline phosphatase levels at 9 months from baseline
Outcome measures
| Measure |
Intensive, Non-Cross Reactive Therapy
n=10 Participants
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Number of Participants With Normal Alkaline Phosphatase Levels
|
8 Participants
|
Adverse Events
Intensive, Non-Cross Reactive Therapy
Serious events: 10 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 participants at risk
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Endocrine disorders
hyperglycemia
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
vomiting
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
diarrhea
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
nausea
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
platelet count decreased
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Hepatobiliary disorders
blood bilirubin increased
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
Other adverse events
| Measure |
Intensive, Non-Cross Reactive Therapy
n=33 participants at risk
Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day
|
|---|---|
|
Endocrine disorders
hyperglycemia
|
21.2%
7/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
vomiting
|
27.3%
9/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
diarrhea
|
51.5%
17/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
nausea
|
42.4%
14/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
39.4%
13/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
platelet count decreased
|
18.2%
6/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
15.2%
5/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
General disorders
fatigue
|
54.5%
18/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
white blood cell count decreased
|
39.4%
13/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
anorexia
|
39.4%
13/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Blood and lymphatic system disorders
anemia
|
39.4%
13/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Cardiac disorders
hypertension
|
9.1%
3/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Hepatobiliary disorders
alanine aminotransferase increased
|
12.1%
4/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Hepatobiliary disorders
aspartate aminotransferase increased
|
15.2%
5/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Cardiac disorders
atrial flutter
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
bloating
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
constipation
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Renal and urinary disorders
creatinine increased
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Nervous system disorders
dizziness
|
9.1%
3/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
dysgeusia
|
15.2%
5/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
dyspepsia
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
dysphagia
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
12.1%
4/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Vascular disorders
edema limbs
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Endocrine disorders
hot flashes
|
18.2%
6/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Immune system disorders
flu like symptoms
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Hepatobiliary disorders
hypoalbuminemia
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Renal and urinary disorders
hypokalemia
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Cardiac disorders
hypotension
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
General disorders
infusion related reaction
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
General disorders
blood lactate dehydrogenase increased
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Musculoskeletal and connective tissue disorders
muscle cramp
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Musculoskeletal and connective tissue disorders
muscle weakness lower limb
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
General disorders
malaise
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
9.1%
3/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Endocrine disorders
hyperhydrosis
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Nervous system disorders
peripheral motor neuropathy
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Nervous system disorders
peripheral sensory neuropathy
|
30.3%
10/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Vascular disorders
phlebitis
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Skin and subcutaneous tissue disorders
maculopapular rash
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Skin and subcutaneous tissue disorders
skin infection
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Renal and urinary disorders
urinary tract pain
|
3.0%
1/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
|
Gastrointestinal disorders
abdominal pain
|
6.1%
2/33 • Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60