SAHA: Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies
Study Details
Study Description
Brief Summary
The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. The investigators want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
Subjects will be treated with vorinostat administered orally with daily dosing for 14 days of a 21-day treatment cycle in combination with niacinamide administered orally for 14 days in 21-day treatment cycle and etoposide administered intravenously on days 8,9 and 10 of a 21-day treatment cycle. Etoposide dose will be escalated until maximum tolerated dose (MTD) is determined.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: V/N: Level 1 Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
|
Experimental: V/N: Level 2 Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
|
Experimental: V/N: Level 3 Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
|
Experimental: V/N: Level 4 Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
|
Experimental: V/N: Level 5 Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
|
Experimental: V/N/E: Level 1 Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
Drug: Etoposide
Dose escalation scheme (0, 25, 50, 100 mg/m2)
Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."
Other Names:
|
Experimental: V/N/E: Level 2 Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
Drug: Etoposide
Dose escalation scheme (0, 25, 50, 100 mg/m2)
Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."
Other Names:
|
Experimental: V/N/E: Level 3 Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2 |
Drug: Vorinostat
Dose escalation scheme (400 mg)
Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
Drug: Niacinamide
Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)
Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
Other Names:
Drug: Etoposide
Dose escalation scheme (0, 25, 50, 100 mg/m2)
Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide [3 years]
Secondary Outcome Measures
- The Greatest Number of Cycles Received in Each Treatment Group [up to 45 weeks]
The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.
- The Number of Dose Delays and Reductions at the MTD [continuous]
- The Prevalence of Anti-tumor Activity [continuous]
- Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies [continuous]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's Disease (WHO criteria), for which they are unwilling or unable to undergo an autologous stem cell transplant
-
Must have received first line chemotherapy. No upper limit to number of prior therapies
-
Evaluable Disease
-
Age >18 years
-
Eastern Cooperative Oncology Group (ECOG) performance status <2
-
Life expectancy of greater than 3 months
-
Patients must have adequate organ and marrow function
-
Adequate Contraception
-
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Prior Therapy
-
Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
-
Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 7 days prior to the start of the study drugs
-
No monoclonal antibody within 3 months unless evidence of progression
-
Patients may not be receiving any other investigational agents
-
Patients with known central nervous system metastases, including lymphomatous meningitis
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, niacinamide or etoposide
-
Uncontrolled intercurrent illness
-
Pregnant women
-
Nursing women
-
Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3 years
-
Patient is known to be Human Immunodeficiency Virus (HIV)-positive
-
Active Hepatitis A, Hepatitis B, or Hepatitis C infection
-
Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Center for Lymphoid Malignancies at CUMC | New York | New York | United States | 10019 |
Sponsors and Collaborators
- Columbia University
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Owen A O'Connor, MD, Ph.D., Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAJ3001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | V/N: Level 2 | V/N: Level 1 | V/N: Level 3 | V/N: Level 4 | V/N: Level 5 | V/N/E: Level 1 | V/N/E: Level 2 | V/N/E: Level 3 |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme |
Period Title: Overall Study | ||||||||
STARTED | 3 | 5 | 3 | 9 | 5 | 7 | 6 | 0 |
COMPLETED | 3 | 5 | 3 | 6 | 5 | 6 | 6 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | V/N: Level 1 | V/N: Level 2 | V/N: Level 3 | V/N: Level 4 | V/N: Level 5 | V/N/E: Level 1 | V/N/E: Level 2 | V/N/E: Level 3 | Total |
---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Total of all reporting groups |
Overall Participants | 5 | 3 | 3 | 9 | 5 | 7 | 6 | 0 | 38 |
Age (Count of Participants) | |||||||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
|
Between 18 and 65 years |
5
100%
|
2
66.7%
|
3
100%
|
7
77.8%
|
3
60%
|
6
85.7%
|
4
66.7%
|
30
Infinity
|
|
>=65 years |
0
0%
|
1
33.3%
|
0
0%
|
2
22.2%
|
2
40%
|
1
14.3%
|
2
33.3%
|
8
Infinity
|
|
Sex: Female, Male (Count of Participants) | |||||||||
Female |
2
40%
|
2
66.7%
|
1
33.3%
|
4
44.4%
|
2
40%
|
2
28.6%
|
2
33.3%
|
15
Infinity
|
|
Male |
3
60%
|
1
33.3%
|
2
66.7%
|
5
55.6%
|
3
60%
|
5
71.4%
|
4
66.7%
|
23
Infinity
|
Outcome Measures
Title | The Greatest Number of Cycles Received in Each Treatment Group |
---|---|
Description | The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long. |
Time Frame | up to 45 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Vorinostat (SAHA) and Niacinamide: Level 1 | Vorinostat (SAHA) and Niacinamide: Level 2 | Vorinostat (SAHA) and Niacinamide: Level 3 | Vorinostat (SAHA) and Niacinamide: Level 4 | Vorinostat (SAHA) and Niacinamide: Level 5 | Vorinostat, Niacinamide and Etoposide: Level 1 | Vorinostat, Niacinamide and Etoposide: Level 2 |
---|---|---|---|---|---|---|---|
Arm/Group Description | Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme |
Measure Participants | 5 | 3 | 3 | 6 | 5 | 6 | 5 |
Number [cycles] |
9
|
12
|
15
|
10
|
14
|
3
|
4
|
Title | The Number of Dose Delays and Reductions at the MTD |
---|---|
Description | |
Time Frame | continuous |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | The Prevalence of Anti-tumor Activity |
---|---|
Description | |
Time Frame | continuous |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies |
---|---|
Description | |
Time Frame | continuous |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | The Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide |
---|---|
Description | |
Time Frame | 3 years |
Outcome Measure Data
Analysis Population Description |
---|
There were no evaluable patients at these levels. |
Arm/Group Title | Vorinostat (SAHA) and Niacinamide: Level 1-5 | Vorinostat, Niacinamide and Etoposide: Level 1-2 |
---|---|---|
Arm/Group Description | Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme |
Measure Participants | 22 | 0 |
Number [mg/kg] |
100
|
Adverse Events
Time Frame | Adverse event data was collected up to 30 days post end of treatment for each patient | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Adverse events were collected by patient reporting and physical exam with an attending and graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). | |||||||||||||
Arm/Group Title | Vorinostat (SAHA) and Niacinamide: Level 1 | Vorinostat (SAHA) and Niacinamide: Level 2 | Vorinostat (SAHA) and Niacinamide: Level 3 | Vorinostat (SAHA) and Niacinamide: Level 4 | Vorinostat (SAHA) and Niacinamide: Level 5 | Vorinostat, Niacinamide and Etoposide: Level 1 | Vorinostat, Niacinamide and Etoposide: Level 2 | |||||||
Arm/Group Description | Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme | |||||||
All Cause Mortality |
||||||||||||||
Vorinostat (SAHA) and Niacinamide: Level 1 | Vorinostat (SAHA) and Niacinamide: Level 2 | Vorinostat (SAHA) and Niacinamide: Level 3 | Vorinostat (SAHA) and Niacinamide: Level 4 | Vorinostat (SAHA) and Niacinamide: Level 5 | Vorinostat, Niacinamide and Etoposide: Level 1 | Vorinostat, Niacinamide and Etoposide: Level 2 | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
Vorinostat (SAHA) and Niacinamide: Level 1 | Vorinostat (SAHA) and Niacinamide: Level 2 | Vorinostat (SAHA) and Niacinamide: Level 3 | Vorinostat (SAHA) and Niacinamide: Level 4 | Vorinostat (SAHA) and Niacinamide: Level 5 | Vorinostat, Niacinamide and Etoposide: Level 1 | Vorinostat, Niacinamide and Etoposide: Level 2 | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/5 (40%) | 1/3 (33.3%) | 0/3 (0%) | 5/9 (55.6%) | 3/5 (60%) | 2/7 (28.6%) | 1/6 (16.7%) | |||||||
Blood and lymphatic system disorders | ||||||||||||||
Anemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Edema | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Cardiac disorders | ||||||||||||||
Hypotension | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Tachycardia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Gastrointestinal disorders | ||||||||||||||
Vomiting | 1/5 (20%) | 1 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Diarrhea | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Soreness in mouth | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
General disorders | ||||||||||||||
Fatigue | 0/5 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 3/9 (33.3%) | 4 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Fever | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Nausea | 0/5 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Death | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Cellulitis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypothermia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hepatobiliary disorders | ||||||||||||||
Liver Failure | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Infections and infestations | ||||||||||||||
Sepsis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
MSSA | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Infection | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 3 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Zoster | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Investigations | ||||||||||||||
Hypoglycemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||||||||
Acidosis | 1/5 (20%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
ALT | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
AST | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Creatinine | 1/5 (20%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 2 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Hyperbilirubinemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hyperkalemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypoalbuminemia | 1/5 (20%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hyponatremia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
INR | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Thrombocytopenia | 1/5 (20%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 3 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Uric Acid | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Anorexia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Neutropenia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypokalemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypomagnesemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypophosphotemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Urea Nitrogen | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||||||
Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 4/9 (44.4%) | 4 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Leg Weakness & Numbness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Weakness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Nervous system disorders | ||||||||||||||
Sensory Neuropathy | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Syncope | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Chord Compression | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Renal and urinary disorders | ||||||||||||||
Hematuria | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||||||
Pneumonia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Cough | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/9 (33.3%) | 5 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Shortness of Breath | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Upper Respiratory Infection | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypoxia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Low CO2 | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Acute Dyspnea | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||||||
Hand-Foot Reaction | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Rash | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Vascular disorders | ||||||||||||||
DVT | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
Vorinostat (SAHA) and Niacinamide: Level 1 | Vorinostat (SAHA) and Niacinamide: Level 2 | Vorinostat (SAHA) and Niacinamide: Level 3 | Vorinostat (SAHA) and Niacinamide: Level 4 | Vorinostat (SAHA) and Niacinamide: Level 5 | Vorinostat, Niacinamide and Etoposide: Level 1 | Vorinostat, Niacinamide and Etoposide: Level 2 | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/5 (100%) | 3/3 (100%) | 3/3 (100%) | 9/9 (100%) | 5/5 (100%) | 7/7 (100%) | 6/6 (100%) | |||||||
Blood and lymphatic system disorders | ||||||||||||||
Acidosis | 1/5 (20%) | 3 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Alk Phos | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
ALT | 2/5 (40%) | 3 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 2/9 (22.2%) | 4 | 1/5 (20%) | 1 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Ammonia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
ANC | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Anemia | 0/5 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 2/9 (22.2%) | 7 | 2/5 (40%) | 3 | 2/7 (28.6%) | 9 | 0/6 (0%) | 0 |
AST | 2/5 (40%) | 3 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 2/9 (22.2%) | 3 | 1/5 (20%) | 1 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Bilateral Lower Extremity Edema | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Creatinine | 1/5 (20%) | 2 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
D-Dimer | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Edema | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/9 (33.3%) | 5 | 1/5 (20%) | 1 | 2/7 (28.6%) | 2 | 0/6 (0%) | 0 |
Elevated Base Excess (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Elevated Creatinine | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 2/5 (40%) | 7 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Elevated Lactate | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Elevated pH (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Elevated PO2 (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Elevated WBC | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Groin Swelling (post -op site) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hematuria | 0/5 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hemoptysis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hyperbilirubinemia | 1/5 (20%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Hypercalcemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 |
Hyperglycemia | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Hyperkalemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypoalbuminemia | 1/5 (20%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Hypoglycemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypokalemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 2/7 (28.6%) | 3 | 0/6 (0%) | 0 |
Hypomagnesemia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hyponatremia | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Hypophosphatemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 2 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
INR | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left Groin Lymph Node Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Low Chloride (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Low CO2 | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Low PCO2 (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Low PO2 (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Metabolic Acidosis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Neutropenia | 1/5 (20%) | 8 | 2/3 (66.7%) | 3 | 0/3 (0%) | 0 | 2/9 (22.2%) | 3 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Nosebleed | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 3 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
O2 saturation | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Proteinuria | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Scrotal and Penile Edema | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Swollen Glands | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Thrombocytopenia | 3/5 (60%) | 6 | 2/3 (66.7%) | 3 | 1/3 (33.3%) | 2 | 2/9 (22.2%) | 4 | 1/5 (20%) | 1 | 1/7 (14.3%) | 4 | 0/6 (0%) | 0 |
Trace Edema | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Urea Nitrogen | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 2 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Uric Acid | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Cardiac disorders | ||||||||||||||
CHF Exacerbation | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Heart Palpitations | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Hypotension | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 1/5 (20%) | 2 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
MAPS (in 50's) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Mild Hypovalemia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Palpitations | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Sinus Tachycardia | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Tachycardia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 3 | 1/5 (20%) | 1 | 2/7 (28.6%) | 3 | 0/6 (0%) | 0 |
Ear and labyrinth disorders | ||||||||||||||
Ear Ache | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Eye disorders | ||||||||||||||
Bloodshot eyes | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dry Eyes | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left Eye Redness | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Ptosis of the right eye | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Eye Redness | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Gastrointestinal disorders | ||||||||||||||
Abdominal Bloating | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 3 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Abdominal Cramping | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Abdominal Discomfort | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Acid Reflux | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Anorexia | 0/5 (0%) | 0 | 2/3 (66.7%) | 4 | 2/3 (66.7%) | 3 | 7/9 (77.8%) | 14 | 2/5 (40%) | 2 | 3/7 (42.9%) | 5 | 3/6 (50%) | 4 |
Bad Taste in Mouth | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Belching | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Blood in Stool | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Bumps on Tongue | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Burning sensation in throat | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Constipation | 1/5 (20%) | 2 | 2/3 (66.7%) | 4 | 3/3 (100%) | 4 | 4/9 (44.4%) | 7 | 2/5 (40%) | 3 | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 |
Decrease in taste | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dehydration | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Diarrhea | 2/5 (40%) | 3 | 2/3 (66.7%) | 2 | 2/3 (66.7%) | 7 | 7/9 (77.8%) | 12 | 3/5 (60%) | 6 | 1/7 (14.3%) | 3 | 1/6 (16.7%) | 3 |
Dry Heaving | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dry Mouth | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Epigastric Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Gagging | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Gas | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 2 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
GERD | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Gums/Teeth tender feeling | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hiccups | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hoarse Voice | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Hyperactivity of the Gut | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Leakage from rectum | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Metallic Taste | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mouth Sore | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mucositis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Nausea | 2/5 (40%) | 3 | 3/3 (100%) | 12 | 3/3 (100%) | 5 | 8/9 (88.9%) | 28 | 5/5 (100%) | 21 | 5/7 (71.4%) | 10 | 3/6 (50%) | 5 |
Petechiae Hard Palate | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Side Mouth Sore | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Soreness in mouth | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Soreness of gumlike | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Stomach Cramps | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Stomach Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Stomach Virus | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Taste Changes | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Tenderness in Mouth, Esophagus, Stomach | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Ulcerations in mouth | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Upset Stomach | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Vomitiing | 1/5 (20%) | 1 | 2/3 (66.7%) | 10 | 2/3 (66.7%) | 3 | 6/9 (66.7%) | 24 | 4/5 (80%) | 7 | 2/7 (28.6%) | 3 | 1/6 (16.7%) | 1 |
General disorders | ||||||||||||||
Death NOS | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hyperactive | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Swollen Cheeks | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Swollen Hands & Feets | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hepatobiliary disorders | ||||||||||||||
Liver Dysfunction | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Liver Failure | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Infections and infestations | ||||||||||||||
Aspergillus fumigatus | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Bacterial SuperInfections and infestations | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Cellulitis (lesion on knee) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Disseminated Zoster | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Infections and infestations (Bacterium gram neg rods) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Neutropenic Spesis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Port Infections and infestations (staphylococcus species, coagulase negative) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Staphyloccus aureus (MSSA) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Transient Viral Infections and infestations | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
URI | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Yeast Infections and infestations | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Zoster | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 3/3 (100%) | 3 | 3/9 (33.3%) | 5 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||||||||
Chills | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 3/9 (33.3%) | 4 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Fatigue | 1/5 (20%) | 1 | 2/3 (66.7%) | 7 | 3/3 (100%) | 9 | 9/9 (100%) | 17 | 5/5 (100%) | 17 | 4/7 (57.1%) | 9 | 2/6 (33.3%) | 2 |
Fever | 1/5 (20%) | 3 | 2/3 (66.7%) | 5 | 2/3 (66.7%) | 4 | 4/9 (44.4%) | 6 | 4/5 (80%) | 4 | 2/7 (28.6%) | 2 | 1/6 (16.7%) | 1 |
General Malaise | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypothermia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Insomnia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Legs Cramps | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Night Sweats | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 2/5 (40%) | 3 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Occasional sweating at night | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Foot Cramp | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Rigors | 3/5 (60%) | 3 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Sore Lymph Nodes(w/ pain) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Sweating | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Weight loss | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||||||
2 episodes of feeling weak & unbalanced | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Abdominal pain | 0/5 (0%) | 0 | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Ache | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 2/5 (40%) | 2 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Body Aches | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Calf Cramping | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Central Disc Herniation | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Chest Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 3 | 2/9 (22.2%) | 2 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Cramping (intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Decrease in Strength | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Discomfort in Stomach (pain) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Hand Cramping | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Headaches | 2/5 (40%) | 2 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 5/9 (55.6%) | 11 | 2/5 (40%) | 9 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Joint Aches | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left Hip Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 2 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left lower quadrant abdominal pain | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left Sided Abdominal Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left Upper Quandrant Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Leg Weakness/numbness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Lower Neck Tighness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mild Increasein Intention Tremor | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mild Neck Soreness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mild Right Knee Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mouth Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Muscle Cramps | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 2 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Muscle Spasms | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Muscular Pain(Buttocks to toes) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Neck Aches (site of enlarged LN) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Ocassional Cramping | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Pleuritic Chest Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Pulled Back Muscle | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Rib Fracture | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Hip Joint Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Groin Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Hip Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Leg Hip Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Lower Back Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Lower Leg Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right rib Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Shoulder Muscle Pain | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Upper Quadrant Pain | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Sinus Headache | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Sore Foot(stepped on nail) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Stiff Fingers | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Suprapubic pain | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
T6/7 & T9/10 Cord Compression | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Toe Cramping | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Upper/Mild Back Spams | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Weakness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Wide based gait when walking | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
T-Cell Lymphoproliferative Disorder | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Nervous system disorders | ||||||||||||||
Headache | 2/5 (40%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 5/9 (55.6%) | 11 | 2/5 (40%) | 8 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Agitated/Irritable Mood | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Anesthesia of Forehead | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Anxiety | 1/5 (20%) | 1 | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 1 | 3/9 (33.3%) | 3 | 1/5 (20%) | 1 | 2/7 (28.6%) | 2 | 1/6 (16.7%) | 1 |
Cramping in Hands & Feet | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Depression | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 4 | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 |
Dizziness | 1/5 (20%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 2/6 (33.3%) | 2 |
Facial Tingling | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Finger Parasthesias | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Lack of Concentration | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Light Headedness | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 2 | 0/6 (0%) | 0 |
Mild Increase in Tremor (in off week) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Neuropathy | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Occational lightheadedness | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Parasthesia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Presyncopal Episode | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Sensory Neuropathy in feet | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Short-term memory loss | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Syncope | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Toe Parasthesias | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Renal and urinary disorders | ||||||||||||||
Burning with Urination | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Clots in Urine | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Difficulty initiating urinary stream | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dysuria | 1/5 (20%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Incontinence | 0/5 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 2/5 (40%) | 2 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Odor with Urination | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 5/9 (55.6%) | 5 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Polyuria | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Strong Odor of Urine | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Urgency with urination | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
UTI | 1/5 (20%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Weak urine stream | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Reproductive system and breast disorders | ||||||||||||||
Cramping (menopausal symptoms) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Decrease Sex Drive | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hot flashes | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Vaginal dryness (menopausal symptoms) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||||||
Acute Dyspnea | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Chest Congestion | 2/5 (40%) | 2 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Chest Pressure | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Chest tightness | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Clear Rhinorrhea | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Cold | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 3/9 (33.3%) | 3 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Collapsed Lung | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Congestion | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Cough | 2/5 (40%) | 3 | 1/3 (33.3%) | 2 | 2/3 (66.7%) | 5 | 4/9 (44.4%) | 10 | 4/5 (80%) | 9 | 2/7 (28.6%) | 2 | 0/6 (0%) | 0 |
Dysphagia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dyspnea (DOE) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 4/9 (44.4%) | 6 | 2/5 (40%) | 4 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Epistaxis (mild & intermittent) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hypoxia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Mild Dyspena | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Mild Sore Throat | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Nasal Congestion | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 3/9 (33.3%) | 4 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Pneumonia (Probable) | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Post Nasal Drip | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Productive Cough | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Rhinorrhea | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Runny Nose | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Shortness of Breath | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 3/9 (33.3%) | 4 | 1/5 (20%) | 3 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Slight cough | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Slight dry cough | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Slight hoarseness | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Sore Throat | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 2/3 (66.7%) | 5 | 2/9 (22.2%) | 4 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Throat Tightening | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Upper Respitatory Infections and infestations | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/9 (33.3%) | 4 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||||||
3 Puncatate skin Leasions on Arm(mosquito bites) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Acne (following RT) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Alopecia | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Armpit Burning | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Burning near rectum (likely zoster related) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dermatitis | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Diffuse Erythematous Rash ( extremeties) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Diffuse PapilarRash ( hypersensitivity reaction) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dry Lips | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Dry Skin | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 2 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Erythematous (slightly on neck) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Eschai of ight index finger | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Flushing | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 4/9 (44.4%) | 6 | 2/5 (40%) | 5 | 3/7 (42.9%) | 3 | 0/6 (0%) | 0 |
Hand- Foot Reaction | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Hives | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
itching | 1/5 (20%) | 2 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Left Breast Itchy Rash | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Left Nipple Bump | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Papular Rash | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 |
Pruritic Rash | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/9 (22.2%) | 3 | 2/5 (40%) | 4 | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 |
Rash (mid area of chest) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Rash(below left breast) | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Rash(blotchy dry spots on hands) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Redness & slight bump on right of nose | 0/5 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Arm Swelling(bug bite) | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Cheek Red Macule | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Right Hand Inflammation(cat scratch) | 1/5 (20%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Skin Lesion lower back | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Skin tenderness on face | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Slight Flushing | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Vascular disorders | ||||||||||||||
DVT ( Left subclavala vein) | 0/5 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Owen A. O'Connor, MD, Ph.D. |
---|---|
Organization | Columbia University Medical Center |
Phone | 212-326-5720 |
oo2130@cumc.columbia.edu |
- AAAJ3001