Trial Outcomes & Findings for Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC) (NCT NCT00452387)
NCT ID: NCT00452387
Last Updated: 2011-09-16
Results Overview
Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.
Results posted on
2011-09-16
Participant Flow
10 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in May 2007 and was closed in July 2008 after the interim analysis was completed.
Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed.
Participant milestones
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC)
Baseline characteristics by cohort
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
n=22 Participants
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age Continuous
|
67 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.Population: Survival analysis was performed for 22 patients. However, the upper 95% confidence interval for median TTP could not be calculated and so the number of patients analyzed and the upper 95% confidence interval for median TTP could not be entered into the system.
Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher's exact test was used to test this hypothesis.
Outcome measures
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
n=9 Participants
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
Imaging Response (Unfavorable)
n=13 Participants
|
|---|---|---|
|
Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging
PSA response (> 50% reduction)
|
3 Participants
|
0 Participants
|
|
Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging
PSA response (< or = 50% reduction)
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5.
Outcome measures
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
n=22 Participants
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
Imaging Response (Unfavorable)
|
|---|---|---|
|
Quality of Life (QoL)
Baseline
|
50.21 units on a scale
Interval 32.95 to 60.27
|
—
|
|
Quality of Life (QoL)
Cycle 1
|
49.71 units on a scale
Interval 30.03 to 59.36
|
—
|
|
Quality of Life (QoL)
Cycle 2
|
51.06 units on a scale
Interval 40.11 to 60.76
|
—
|
|
Quality of Life (QoL)
Cycle 3
|
51.20 units on a scale
Interval 34.63 to 60.08
|
—
|
|
Quality of Life (QoL)
Cycle 4
|
51.66 units on a scale
Interval 44.31 to 57.5
|
—
|
|
Quality of Life (QoL)
Cycle 5
|
51.22 units on a scale
Interval 42.5 to 59.36
|
—
|
|
Quality of Life (QoL)
Cycle 6
|
49.73 units on a scale
Interval 38.59 to 55.61
|
—
|
|
Quality of Life (QoL)
Cycle 7
|
49.50 units on a scale
Interval 38.16 to 59.36
|
—
|
|
Quality of Life (QoL)
Cycle 8
|
48.20 units on a scale
Interval 35.91 to 59.18
|
—
|
|
Quality of Life (QoL)
Cycle 9
|
54.34 units on a scale
Interval 52.69 to 56.01
|
—
|
|
Quality of Life (QoL)
Cycle 10
|
55.88 units on a scale
Interval 51.38 to 59.01
|
—
|
|
Quality of Life (QoL)
Cycle 11
|
54.95 units on a scale
Interval 54.95 to 54.95
|
—
|
|
Quality of Life (QoL)
Cycle 12
|
54.02 units on a scale
Interval 51.47 to 56.55
|
—
|
|
Quality of Life (QoL)
Cycle 13
|
54.65 units on a scale
Interval 54.65 to 54.65
|
—
|
|
Quality of Life (QoL)
End of Study (at treatment discontinuation)
|
45.13 units on a scale
Interval 40.2 to 53.72
|
—
|
SECONDARY outcome
Timeframe: Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death.Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Outcome measures
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
n=22 Participants
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
Imaging Response (Unfavorable)
|
|---|---|---|
|
Median Overall Survival (OS)
|
12.32 Months
Interval 7.82 to 22.5
|
—
|
Adverse Events
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
n=22 participants at risk
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Acute gastritis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Pain - abdominal
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Death
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Necrosis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pain - chest
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Acute osteomylitis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Esophageal candidiasis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of mandible
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - hip
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - jaw
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - shoulder
|
4.5%
1/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Lower extremities paraparesis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Deep vein thrombosis of lower extremity
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic small cell lung cancer
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
Other adverse events
| Measure |
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib
n=22 participants at risk
The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.6%
3/22 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
1/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.7%
5/22 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
1/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Blurred vision
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Eye floaters
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Watery eyes
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Anal buccal tenderness
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
6/22 • Number of events 6 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Bloating
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Change in taste of food
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
8/22 • Number of events 10 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dry heaves
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Gastrointestinal - abdomen NOS (intermittent)
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Heartburn
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Hemoccult positive stools
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Melanotic stools
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Mouth sores
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Nausea
|
40.9%
9/22 • Number of events 12 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Pain - abdomen
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Pain - esophagus
|
4.5%
1/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Peridontal disease
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Sore mouth
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22 • Number of events 7 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Ankle edema
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Bilateral lower extremity edema
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue
|
59.1%
13/22 • Number of events 14 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Flu-like symptoms
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Mucositis
|
36.4%
8/22 • Number of events 8 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pain - chest
|
13.6%
3/22 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Rigors without temperature
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Weakness
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Bronchitis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Diverticulitis
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Herpes zoster
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Positive blood cultures
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Shingles
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Upper respiratory infection
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
T12 compression fracture
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Cardiac catheter
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Decreased ejection fraction
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated ALT
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated AST
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated blood pressure
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Elevated liver enzymes
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Fever
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
2/22 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
1/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Weight gain
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Weight loss
|
31.8%
7/22 • Number of events 7 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Cramping - bilateral feet
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Cramping - bilateral hands
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - abdominal
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - hip
|
18.2%
4/22 • Number of events 6 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - jaw
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - lower back
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - muscles
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - right flank
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - shoulder
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - thighs
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Weakness - legs
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Disequilibrium
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Neuropathy
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Neuropathy - peripheral
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Neuropathy - sensory
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Pain - sinus
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Mental status change
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Frequent urination
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.3%
6/22 • Number of events 10 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
1/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.2%
4/22 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Erythema - face
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Erythema - feet
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Numbness in face
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Onycholysis right thumbnail
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritis / itching scalp
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
4/22 • Number of events 4 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash - back
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash - face
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash - generalized
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash - hand/foot/scalp
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash - mouth
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash - hand and foot
|
4.5%
1/22 • Number of events 3 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Ruddy complexion
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Sensory neuropathy sensitivity - feet
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Tingling on scalp
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Surgical and medical procedures
Stent placement
|
4.5%
1/22 • Number of events 1 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypertension
|
18.2%
4/22 • Number of events 5 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • Number of events 2 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle by either the research coordiantor, treating physician, or other appropriate sub-investigator.
|
Additional Information
Vice President of Scientific Affairs
Accelerated Community Oncology Research Network, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication or presentation of Sponsored Research results, Researcher agrees to provide Bayer with such presentation or manuscript at least 30 days prior to its submission for the sole purpose of allowing Bayer to redact confidential information and protect any existing or future patents. The Principal Investigator shall acknowledge Bayer contributions where appropriate.
- Publication restrictions are in place
Restriction type: OTHER