Trial Outcomes & Findings for Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma (NCT NCT00366106)
NCT ID: NCT00366106
Last Updated: 2012-04-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Every 4 weeks from start of treatment until end of treatment
Results posted on
2012-04-06
Participant Flow
15 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in July 2006 but was stopped in December 2008 at the point when it became clear that enrollment was too slow to complete the planned enrollment target of 45 patients within the time frame allowed.
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Participant milestones
| Measure |
Treatment Group
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment Group
n=32 Participants
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age Continuous
|
63.7 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 4 weeks from start of treatment until end of treatmentOutcome measures
| Measure |
Treatment Group
n=32 Participants
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
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|---|---|
|
Incidence of Treatment-emergent Peripheral Neuropathy
|
11 Participants
|
SECONDARY outcome
Timeframe: TTP was measured from day 1 of treatment until time of progression, assessed up to 40 monthsOutcome measures
| Measure |
Treatment Group
n=32 Participants
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
|
|---|---|
|
Time to Progression (TTP)
|
23.07 Months
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Every 8 weeks from start of treatment until end of treatmentComplete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and \<5% plasma cells in bone marrow. PR also required \>=50% SPEP reduction, \>=90% UPEP reduction, and \>=50% reduction in plasma cells in bone marrow. MR also required \>=25% SPEP reduction, \>=50% UPEP reduction, and \> 25% reduction in plasma cells.
Outcome measures
| Measure |
Treatment Group
n=32 Participants
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
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|---|---|
|
Number of Participants With Treatment Response
|
NA Participants
We were unable to assess participant response to treatment due to missingness of data required for determination of response.
|
SECONDARY outcome
Timeframe: Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)Population: Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.
Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.
Outcome measures
| Measure |
Treatment Group
n=32 Participants
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
|
|---|---|
|
Relative Dose Intensity of Bortezomib
Cycle 11 / Week 41 Day 4
|
1.00 Relative dose intensity
Standard Deviation NA
Only 1 patient was dosed.
|
|
Relative Dose Intensity of Bortezomib
Cycle 2 / Week 5
|
0.95 Relative dose intensity
Standard Deviation 0.144
|
|
Relative Dose Intensity of Bortezomib
Cycle 2 / Week 5 Day 4
|
0.96 Relative dose intensity
Standard Deviation 0.148
|
|
Relative Dose Intensity of Bortezomib
Cycle 1 / Week 1
|
0.97 Relative dose intensity
Standard Deviation 0.158
|
|
Relative Dose Intensity of Bortezomib
Cycle 1 / Week 1 Day 4
|
0.98 Relative dose intensity
Standard Deviation 0.159
|
|
Relative Dose Intensity of Bortezomib
Cycle 1 / Week 3
|
0.97 Relative dose intensity
Standard Deviation 0.158
|
|
Relative Dose Intensity of Bortezomib
Cycle 1 / Week 3 Day 18
|
0.97 Relative dose intensity
Standard Deviation 0.154
|
|
Relative Dose Intensity of Bortezomib
Cycle 2 / Week 7
|
0.95 Relative dose intensity
Standard Deviation 0.140
|
|
Relative Dose Intensity of Bortezomib
Cycle 2 / Week 7 Day 18
|
0.96 Relative dose intensity
Standard Deviation 0.146
|
|
Relative Dose Intensity of Bortezomib
Cycle 3 / Week 9
|
0.99 Relative dose intensity
Standard Deviation 0.147
|
|
Relative Dose Intensity of Bortezomib
Cycle 3 / Week 9 Day 4
|
0.97 Relative dose intensity
Standard Deviation 0.121
|
|
Relative Dose Intensity of Bortezomib
Cycle 3 / Week 11
|
0.97 Relative dose intensity
Standard Deviation 0.142
|
|
Relative Dose Intensity of Bortezomib
Cycle 3 / Week 11 Day 18
|
0.95 Relative dose intensity
Standard Deviation 0.104
|
|
Relative Dose Intensity of Bortezomib
Cycle 4 / Week 13
|
0.99 Relative dose intensity
Standard Deviation 0.152
|
|
Relative Dose Intensity of Bortezomib
Cycle 4 / Week 13 Day 4
|
0.96 Relative dose intensity
Standard Deviation 0.111
|
|
Relative Dose Intensity of Bortezomib
Cycle 4 / Week 15
|
0.99 Relative dose intensity
Standard Deviation 0.154
|
|
Relative Dose Intensity of Bortezomib
Cycle 4 / Week 15 Day 18
|
0.96 Relative dose intensity
Standard Deviation 0.111
|
|
Relative Dose Intensity of Bortezomib
Cycle 5 / Week 17
|
0.98 Relative dose intensity
Standard Deviation 0.151
|
|
Relative Dose Intensity of Bortezomib
Cycle 5 / Week 17 Day 4
|
0.96 Relative dose intensity
Standard Deviation 0.110
|
|
Relative Dose Intensity of Bortezomib
Cycle 5 / Week 19
|
1.00 Relative dose intensity
Standard Deviation 0.157
|
|
Relative Dose Intensity of Bortezomib
Cycle 5 / Week 19 Day 18
|
0.97 Relative dose intensity
Standard Deviation 0.111
|
|
Relative Dose Intensity of Bortezomib
Cycle 6 / Week 21
|
1.01 Relative dose intensity
Standard Deviation 0.162
|
|
Relative Dose Intensity of Bortezomib
Cycle 6 / Week 21 Day 4
|
0.98 Relative dose intensity
Standard Deviation 0.114
|
|
Relative Dose Intensity of Bortezomib
Cycle 6 / Week 23
|
1.01 Relative dose intensity
Standard Deviation 0.169
|
|
Relative Dose Intensity of Bortezomib
Cycle 6 / Week 23 Day 18
|
0.99 Relative dose intensity
Standard Deviation 0.115
|
|
Relative Dose Intensity of Bortezomib
Cycle 7 / Week 25
|
1.11 Relative dose intensity
Standard Deviation 0.154
|
|
Relative Dose Intensity of Bortezomib
Cycle 7 / Week 25 Day 4
|
1.03 Relative dose intensity
Standard Deviation 0.148
|
|
Relative Dose Intensity of Bortezomib
Cycle 7 / Week 27
|
1.08 Relative dose intensity
Standard Deviation 0.198
|
|
Relative Dose Intensity of Bortezomib
Cycle 7 / Week 27 Day 18
|
1.03 Relative dose intensity
Standard Deviation 0.148
|
|
Relative Dose Intensity of Bortezomib
Cycle 8 / Week 29
|
1.05 Relative dose intensity
Standard Deviation 0.213
|
|
Relative Dose Intensity of Bortezomib
Cycle 8 / Week 29 Day 4
|
0.99 Relative dose intensity
Standard Deviation 0.140
|
|
Relative Dose Intensity of Bortezomib
Cycle 8 / Week 31
|
1.05 Relative dose intensity
Standard Deviation 0.213
|
|
Relative Dose Intensity of Bortezomib
Cycle 8 / Week 31 Day 18
|
1.04 Relative dose intensity
Standard Deviation 0.085
|
|
Relative Dose Intensity of Bortezomib
Cycle 9 / Week 33
|
1.10 Relative dose intensity
Standard Deviation 0.488
|
|
Relative Dose Intensity of Bortezomib
Cycle 9 / Week 33 Day 4
|
0.75 Relative dose intensity
Standard Deviation NA
Only 1 patient was dosed.
|
|
Relative Dose Intensity of Bortezomib
Cycle 9 / Week 35
|
1.15 Relative dose intensity
Standard Deviation 0.417
|
|
Relative Dose Intensity of Bortezomib
Cycle 10 / Week 37
|
1.22 Relative dose intensity
Standard Deviation 0.311
|
|
Relative Dose Intensity of Bortezomib
Cycle 10 / Week 37 Day 4
|
1.00 Relative dose intensity
Standard Deviation NA
Only 1 patient was dosed.
|
|
Relative Dose Intensity of Bortezomib
Cycle 10 / Week 39
|
1.22 Relative dose intensity
Standard Deviation 0.311
|
|
Relative Dose Intensity of Bortezomib
Cycle 10 / Week 39 Day 18
|
1.00 Relative dose intensity
Standard Deviation NA
Only 1 patient was dosed.
|
|
Relative Dose Intensity of Bortezomib
Cycle 11 / Week 41
|
1.22 Relative dose intensity
Standard Deviation 0.311
|
|
Relative Dose Intensity of Bortezomib
Cycle 11 / Week 43
|
1.44 Relative dose intensity
Standard Deviation NA
Only 1 patient was dosed.
|
|
Relative Dose Intensity of Bortezomib
Cycle 11 / Week 43 Day 18
|
1.00 Relative dose intensity
Standard Deviation NA
Only 1 patient was dosed.
|
Adverse Events
Treatment Group
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=32 participants at risk
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Herpes zoster
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood creatinine increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hyperglycemic hyperosmolar nonketotic syndrome
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Mental status changes
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Renal failure
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Renal failure acute
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
Other adverse events
| Measure |
Treatment Group
n=32 participants at risk
All subjects received bortezomib 1.3mg/m\^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m\^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
15.6%
5/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Hemorrhagic diathesis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Ear and labyrinth disorders
Ear pain
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Eye discharge
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Eye irritation
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Lacrimation increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Ocular surface disease
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Vision blurred
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Visual impairment
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Constipation
|
34.4%
11/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
21.9%
7/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Glossodynia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
8/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Oral pain
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
7/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Asthenia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Chest pain
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Chills
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Face edema
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Facial pain
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue
|
28.1%
9/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Lethargy
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Mucosal inflammation
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Edema peripheral
|
21.9%
7/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pain
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pyrexia
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Abscess jaw
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Eye infection
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Herpes zoster
|
12.5%
4/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Oral fungal infection
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Skin infection
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Urinary tract infections
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
Barotitis media
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
Vaginal laceration
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood creatine increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood creatinine increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood glucose increased
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood potassium decreased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood potassium increased
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Blood urea decreased
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Hemoglobin decreased
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Heart rate increased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Platelet count decreased
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Weight decreased
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Weight increased
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Increased appetite
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Amnesia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Burning feet syndrome
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Burning sensation
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
4/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Hypoesthesia
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Migraine
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Neuralgia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Neuropathy peripheral
|
34.4%
11/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Paresthesia
|
15.6%
5/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Parosmia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Syncope
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Depression
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Insomnia
|
12.5%
4/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Nervousness
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Vaginal mucosal blistering
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
7/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
4/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
4/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
2/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Ecchymosis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Orthostatic hypotension
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Phlebitis
|
3.1%
1/32 • 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 weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
Additional Information
Vice President of Scientific Affairs
Accelerated Community Oncology Research Network, Inc.
Phone: 901-435-5570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the disclosure must be given to Millennium for review at least 30 days before it is submitted for publication or disclosure. If a Development is contained in the disclosure, Research Organization and/or Principal Investigator defer publication or disclosure for 90 days from the time Millennium notifies that it wants to file a patent application on the Development provided such notice was provided by Millennium within 30 days of the copy first provided to Millennium.
- Publication restrictions are in place
Restriction type: OTHER