Trial Outcomes & Findings for Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy (NCT NCT01083368)
NCT ID: NCT01083368
Last Updated: 2019-08-21
Results Overview
Participants received temsirolimus (20mg or 25mg IV weekly) in combination with a fixed dose of IV bevacizumab (10mg/kg every 2 weeks). The MTD was determined to be the dose at which no unacceptable toxicities were observed.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
at 24 weeks
Results posted on
2019-08-21
Participant Flow
Subjects were recruited from medical clinics from 3/2009 to 7/2011
22 participants were enrolled, but only 21 treated because one participant withdrew before start of protocol therapy.
Participant milestones
| Measure |
Dose Level -1
Temsirolimus 15 mg IV q wk with Bevacizumab 5 mg/kg IV q 2 wks
This is a de-escalation dose levels and no participants ended up receiving this dose level.
|
Dose Level 0
Temsirolimus 15 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
This is a de-escalation dose levels, and no participants ended up receiving this dose level.
|
Dose Level 1
Temsirolimus 20 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
|
Dose Level 2
Temsirolimus 25 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
|
|---|---|---|---|---|
|
Dose Escalation Weeks 1-4
STARTED
|
0
|
0
|
4
|
0
|
|
Dose Escalation Weeks 1-4
Disease Progression
|
0
|
0
|
1
|
0
|
|
Dose Escalation Weeks 1-4
COMPLETED
|
0
|
0
|
4
|
0
|
|
Dose Escalation Weeks 1-4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Escalation Weeks 5-9
STARTED
|
0
|
0
|
1
|
6
|
|
Dose Escalation Weeks 5-9
COMPLETED
|
0
|
0
|
1
|
6
|
|
Dose Escalation Weeks 5-9
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II - Efficacy/Safety
STARTED
|
0
|
0
|
0
|
20
|
|
Phase II - Efficacy/Safety
COMPLETED
|
0
|
0
|
0
|
20
|
|
Phase II - Efficacy/Safety
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=4 Participants
Temsirolimus 20 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
|
Dose Level 2
n=17 Participants
Temsirolimus 25 mg IV q wk with Bevacizumab 10 mg/kg IV q 2 wks
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-59 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
17 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 weeksPopulation: Subjects that received treatment for the Dose escalation portion of the study.
Participants received temsirolimus (20mg or 25mg IV weekly) in combination with a fixed dose of IV bevacizumab (10mg/kg every 2 weeks). The MTD was determined to be the dose at which no unacceptable toxicities were observed.
Outcome measures
| Measure |
Dose Levels 1 and 2
n=6 Participants
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Temsirolimus (Phase I)
|
25 mg
|
PRIMARY outcome
Timeframe: change from baseline to 12 weeksPopulation: Participants with available serial PSA data (at both baseline and 12 weeks) who received the MTD dose of Temsirolimus 25 mg.
PSA (Prostate-Specific Antigen) test will be performed every 4 weeks prior to receiving treatment. PSA response will be measured as the number of participants that had a decline observed from baseline.
Outcome measures
| Measure |
Dose Levels 1 and 2
n=16 Participants
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Response (Dose Level 2)
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants that received treatment. Data no longer available per intervention arms - reported combined.
To evaluate the effect of the combination of temsirolimus and AVASTIN on time (in months) to clinical progression from start of treatment. Progressive Disease according to RECIST Criteria is defined as : At least a 20% increase in the sum of the 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
Outcome measures
| Measure |
Dose Levels 1 and 2
n=21 Participants
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Time to Clinical Progression
|
2.6 months
Interval 1.2 to 3.9
|
SECONDARY outcome
Timeframe: baseline to end of study, up to 3.5 yearsPopulation: All participants that received treatment. Data no longer available per intervention arms - reported combined.
Time in months from on study to time of death
Outcome measures
| Measure |
Dose Levels 1 and 2
n=21 Participants
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
8 months
Interval 3.0 to 42.0
|
SECONDARY outcome
Timeframe: at 24 weeksPopulation: All participants who received treatment at the MTD (Dose level 2)
To further evaluate the safety of temsirolimus given in combination with AVASTIN in chemotherapy refractory metastatic CRPC patients at the dose established in our phase I safety phase. Specific toxicities are listed in the SAE and AE results.
Outcome measures
| Measure |
Dose Levels 1 and 2
n=17 Participants
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Patients With Toxicity as Assessed by CTCAE v3.0 (Common Toxicity Criteria for Adverse Effects)
|
17 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at end of treatmentTo determine the presence of circulating tumor cells (CTCs) and status of single nucleotide polymorphism (SNPs) in CRPC patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at baselinePopulation: All participants that received treatment for both arms. Data no longer available per intervention arms - reported combined.
Prostate Specific Androgen (PSA) at baseline
Outcome measures
| Measure |
Dose Levels 1 and 2
n=21 Participants
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Prostate Specific Androgen (PSA)
|
205.3 ng/mL
Interval 11.1 to 1801.0
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Level 2
Serious events: 7 serious events
Other events: 20 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Dose Level 2
n=20 participants at risk
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Confusion
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
0.00%
0/20 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
0.00%
0/20 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lung (pneumonia)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Pelvic
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Back
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Extremity-limb
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Pelvis
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Weight loss
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
Other adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Dose Level 2
n=20 participants at risk
Patients receive temsirolimus IV over 30-60 minutes once weekly and bevacizumab IV over 30-90 minutes once every two weeks . Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
temsirolimus: Given IV
bevacizumab: Given IV
polymorphism analysis: Correlative studies
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
4/4 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
60.0%
12/20 • Number of events 20 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 6 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
50.0%
2/4 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
25.0%
5/20 • Number of events 16 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
45.0%
9/20 • Number of events 12 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block - Asystole
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
25.0%
5/20 • Number of events 8 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Psychiatric disorders
Constitutional Symptoms - Cold intolerance
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Psychiatric disorders
Constitutional Symptoms - Change of mental sttatus
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 6 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - hyperpigmentation-hands
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
25.0%
5/20 • Number of events 7 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
0.00%
0/20 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Vascular disorders
Edema: limb
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
35.0%
7/20 • Number of events 13 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Vascular disorders
Edema: trunk/genital
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
4/4 • Number of events 10 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
60.0%
12/20 • Number of events 35 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Infections and infestations
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Fistula, GI - Oral cavity
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Fistula, GI - Stomach
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Gastrointestinal - early satiety
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
rectal fissure
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
40.0%
8/20 • Number of events 9 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
0.00%
0/20 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
4/4 • Number of events 14 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
45.0%
9/20 • Number of events 18 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Renal and urinary disorders
Hemorrhage, GU - Bladder
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
30.0%
6/20 • Number of events 11 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Endocrine disorders
Hot flashes/flushes
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Cardiac disorders
Hypertension
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 7 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Insomnia
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
30.0%
6/20 • Number of events 6 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
50.0%
2/4 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
35.0%
7/20 • Number of events 16 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
2/4 • Number of events 12 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
75.0%
15/20 • Number of events 46 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 8 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Mood alteration - Agitation
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Mood alteration - Anxiety
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Mood alteration - Depression
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
50.0%
2/4 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
25.0%
5/20 • Number of events 8 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Anus
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Esophagus
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
40.0%
8/20 • Number of events 11 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Rectum
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Ocular
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue -muscle aches in legs
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
45.0%
9/20 • Number of events 19 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Neurology - decreased motivation
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 6 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
25.0%
1/4 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 6 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Abdomen NOS
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Pain - Anus
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Back
|
75.0%
3/4 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
30.0%
6/20 • Number of events 10 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Bone
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Buttock
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Chest wall
|
50.0%
2/4 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Extremity-limb
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
30.0%
6/20 • Number of events 9 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Head/headache
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Joint
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
40.0%
8/20 • Number of events 14 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
25.0%
5/20 • Number of events 8 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Neck
|
50.0%
2/4 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Oral cavity
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Diffuse pain;back,shoulders,hips,legs,ribs
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - L and R thigh
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Pelvis
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Peritoneum
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Pleura
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 7 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Pain - Urethra
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Blood and lymphatic system disorders
Platelets
|
75.0%
3/4 • Number of events 6 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
50.0%
10/20 • Number of events 25 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 9 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Proteinuria
|
50.0%
2/4 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
25.0%
5/20 • Number of events 5 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 7 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
15.0%
3/20 • Number of events 7 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Rigors/chills
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
30.0%
6/20 • Number of events 9 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
10.0%
2/20 • Number of events 3 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
30.0%
6/20 • Number of events 13 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
75.0%
3/4 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
40.0%
8/20 • Number of events 12 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
40.0%
8/20 • Number of events 12 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
20.0%
4/20 • Number of events 7 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
|
Gastrointestinal disorders
Weight loss
|
100.0%
4/4 • Number of events 4 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
45.0%
9/20 • Number of events 15 • Adverse event data was collected while participants were on study up to 3 1/2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place