Trial Outcomes & Findings for Multimodality Phase II Study in Prostate Cancer (NCT NCT00734851)
NCT ID: NCT00734851
Last Updated: 2015-12-23
Results Overview
Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
2 years
Results posted on
2015-12-23
Participant Flow
36 participants consented. 2 participants withdrew consent prior to going on treatment. 34 participants started treatment. 2 participants withdrew while on treatment. 18 withdrawn by PI.
Participant milestones
| Measure |
Multimodality
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Multimodality
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
18
|
Baseline Characteristics
Multimodality Phase II Study in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Multimodality
n=34 Participants
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Age, Continuous
|
60.76 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPercentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.
Outcome measures
| Measure |
Multimodality
n=34 Participants
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
The Rate of Progression Free Survival (PFS) at 24 Months
|
51 percentage of patients
Interval 33.0 to 67.0
|
SECONDARY outcome
Timeframe: 24 months and 36 monthsPercentage of participants surviving 24 and 36 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount or a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks. Please note: bPFS is identical to PFS but includes only PSA-based endpoints or death.
Outcome measures
| Measure |
Multimodality
n=34 Participants
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.
24 Months
|
51 percentage of patients
Interval 33.0 to 67.0
|
|
Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.
36 Months
|
48 percentage of patients
Interval 29.0 to 64.0
|
SECONDARY outcome
Timeframe: 24 months and 36 monthsLocal recurrence is defined as men with locally recurrent disease confirmed pathologically within the radiation field, and is estimated at 2 and 3 years.
Outcome measures
| Measure |
Multimodality
n=34 Participants
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Rate of Local Recurrence at 2 and 3 Years
24 Months
|
0 percentage of participants
|
|
Rate of Local Recurrence at 2 and 3 Years
36 Months
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 and 3 yearsPopulation: This rate is not estimable as 0 patients had locally recurrent disease before being taken off study for biochemical progression.
MFS is defined as the length of time between the date of start of treatment and the date of evidence of systemic disease on bone scan or cross sectional imaging or death, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 1 yearPopulation: Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.
A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline, at 3 months after completing radiotherapy, at 12 months, and at 2 and 3 years of follow-up for a total of 5 possible surveys per patient. Due to a low number of completed surveys at the fourth and fifth time point, the difference between the 12 month time point and baseline is summarized. Negative values indicate a decrease in QoL, while positive numbers represent an increase.
Outcome measures
| Measure |
Multimodality
n=21 Participants
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Change in Quality of Life (QoL) After 1 Year
Urinary Irritative (N=20)
|
0 units on a scale
Interval -75.0 to 12.5
|
|
Change in Quality of Life (QoL) After 1 Year
Urinary Incontinence (N=21)
|
0 units on a scale
Interval -91.75 to 29.0
|
|
Change in Quality of Life (QoL) After 1 Year
Bowel (N=19)
|
0 units on a scale
Interval -50.0 to 29.17
|
|
Change in Quality of Life (QoL) After 1 Year
Sexual (N=21)
|
0 units on a scale
Interval -12.5 to 63.83
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.
A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline and 3 months after completing radiotherapy. Negative values indicate a decrease in QoL, while positive numbers represent an increase.
Outcome measures
| Measure |
Multimodality
n=32 Participants
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Change in Quality of Life (QoL) After 3 Month
Urinary Irritative (N=29)
|
0 units on a scale
Interval -25.0 to 43.75
|
|
Change in Quality of Life (QoL) After 3 Month
Urinary Incontinence (N=31)
|
-6 units on a scale
Interval -25.0 to 25.25
|
|
Change in Quality of Life (QoL) After 3 Month
Bowel (N=32)
|
0 units on a scale
Interval -29.17 to 24.17
|
|
Change in Quality of Life (QoL) After 3 Month
Sexual (N=30)
|
0 units on a scale
Interval -37.5 to 26.33
|
SECONDARY outcome
Timeframe: 2 and 3 yearsPopulation: Due to the unavailability of tissue, this outcome was not performed.
Prospective collection of prostate tissue at the time of radical prostatectomy is routinely performed at Duke. These samples will be analyzed by laser capture microdissection (LCM) for genomic profiling by RNA expression analysis for all subjects with tissue available. The expression profiles of subjects who experience PSA recurrence after protocol therapy by the 24 month endpoint will be compared with the expression profiles of subjects without recurrence at this time point as an exploratory measure to predict aggressive prostate cancer and those subjects who are unlikely to benefit from this approach. Baseline prostate tumor biomarkers in the form of RNA expression profiles will be correlated with 2 year PFS in an exploratory analysis. The median bPFS of those with detectable biomarker expression is reported.
Outcome measures
Outcome data not reported
Adverse Events
Multimodality
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multimodality
n=34 participants at risk
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Hepatobiliary disorders
Cholecystitis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Fracture
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
Multimodality
n=34 participants at risk
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
26.5%
9/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Dermatology,
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Inflamation
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Vascular disorders - Other, specify: Bleeding, rectal with bowel move
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Vascular disorders - Other, specify: bronchitis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Vitiligo
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: rash
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: thinning ski
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Flushing
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hot flashes
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypertension
|
20.6%
7/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Blood and lymphatic system disorders
Anemia
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: Ear Wax
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Blurred vision
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Dry eye
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Extraocular muscle paresis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Watering eyes
|
17.6%
6/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Anal mucositis
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Anal pain
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Cheilitis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
70.6%
24/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dyspepsia
|
41.2%
14/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Blood in stool
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: GERD
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Indigestion
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Mouth sensitivity
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: intermittent bloody stoo
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: stomach ache
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
32.4%
11/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
38.2%
13/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Toothache
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Chills
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema face
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
91.2%
31/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
20.6%
7/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Pain
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Allergic reaction
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Immune system disorders - Other, specify: Facial Flushing
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Immune system disorders - Other, specify: lower back pain/raised rash
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Bronchial infection
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify: Bronchitis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify: Infection with Grade 3
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify: Upper Respiratory Infec
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify: oral
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Skin infection
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Tooth infection
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Arterial injury
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Creatinine increased
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Lymphocyte count decreased
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight gain
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight loss
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
White blood cell decreased
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.6%
7/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
47.1%
16/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: rig
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysgeusia
|
82.4%
28/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
26.5%
9/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Paresthesia
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Oculomotor nerve disorder
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.5%
8/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Trigeminal nerve disorder
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Bladder spasm
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Dysuria
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Hematuria
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary frequency
|
17.6%
6/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary incontinence
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.8%
4/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
6/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
17.6%
6/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.8%
3/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Pha
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Upp
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: bro
|
2.9%
1/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
79.4%
27/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.6%
7/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
2/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
14.7%
5/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
29.4%
10/34 • 36 Months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place