Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT01757171
Collaborator
Sanofi (Industry)
85
5
2
54
17
0.3
Study Details
Study Description
Brief Summary
Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy.
At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Prior to initiating protocol therapy, patients will undergo screening evaluations, to be done within 30 days of protocol initiation unless otherwise noted.
Patients who are taxane naïve will be assigned to arm A and patients who have had prior taxane therapy will be assigned to Arm B. Each arm will be analyzed separately for the primary study endpoint of 3 month progression free survival rate (PFS), as defined as the time from the start of treatment to the date of disease progression or death. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks.
In the absence of treatment delays due to adverse event(s), treatment may continue until disease progression; intercurrent illness that prevents further administration of treatment; unacceptable adverse event(s); patient decides to withdraw; general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Patients will be followed for 6 months after removal from study or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.
Study Design
Study Type:
Interventional
Actual Enrollment
:
85 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Actual Study Start Date
:
Dec 1, 2012
Actual Primary Completion Date
:
Jul 1, 2016
Actual Study Completion Date
:
Jun 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A (taxane naïve) No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks |
Drug: Cabazitaxel
20mg IV over 1 hour every 3 weeks
|
| Experimental: Arm B (prior taxane therapy) Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks |
Drug: Cabazitaxel
20mg IV over 1 hour every 3 weeks
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Progression at the 3 Month Follow up Visit [3 months]
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Results below list the number of participants who progressed at the 3 month follow up visit
Secondary Outcome Measures
- Duration of Event Free Survival of Subjects Treated With Cabazitaxel [From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months]
To examine other measures of efficacy such as overall progression free in all evaluable patients
- Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes [From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Percent of Participants Treated With Cabazitaxel With Event Free Survival [From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months]
To examine other measures of efficacy such as overall survival in all evaluable patients
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
-
Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
-
Subject must have evaluable disease as per RECIST criteria.
-
Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
-
Age >/=18 years old.
-
ECOG performance status status >/= 2
-
Subject must have normal organ and marrow function as defined below:
-
WBC >/= 3,000/uL
-
Total Bilirubin ≤ 1.5 x upper limits of normal
-
AST (SGOT) ≤ 2.5 x upper limits of normal
-
ALT (SGPT) ≤ 2.5 x upper limits of normal
-
Hgb > 7.5 g/dl (without transfusion within 7 days)
-
ANC > 1000 /ml
-
Plt > 75 K/ml (without transfusion)
-
Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
-
Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
-
Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
-
Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event.
-
Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:
a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement
-
Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from prior treatment related toxicity with persistent symptoms >/= grade 2 due to agents administered more than 4 weeks earlier.
-
Subject may not receive another investigational agent.
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
-
Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
| 2 | Yale University | New Haven | Connecticut | United States | 06510 |
| 3 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 4 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 5 | Weill Cornell Medical College | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Sanofi
Investigators
- Principal Investigator: Manish Shah, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01757171
Other Study ID Numbers:
- 1208012946
First Posted:
Dec 28, 2012
Last Update Posted:
Apr 3, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Weill Medical College of Cornell University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) |
|---|---|---|
| Arm/Group Description | Arm A - No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Arm B - Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks |
| Period Title: Overall Study | ||
| STARTED | 61 | 24 |
| COMPLETED | 53 | 23 |
| NOT COMPLETED | 8 | 1 |
Baseline Characteristics
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) | Total |
|---|---|---|---|
| Arm/Group Description | No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Total of all reporting groups |
| Overall Participants | 53 | 23 | 76 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
62.1
|
57.34
|
61.67
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
37.7%
|
6
26.1%
|
26
34.2%
|
| Male |
33
62.3%
|
17
73.9%
|
50
65.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
5
9.4%
|
4
17.4%
|
9
11.8%
|
| Not Hispanic or Latino |
36
67.9%
|
14
60.9%
|
50
65.8%
|
| Unknown or Not Reported |
12
22.6%
|
5
21.7%
|
17
22.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
7
13.2%
|
1
4.3%
|
8
10.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
1.9%
|
0
0%
|
1
1.3%
|
| White |
36
67.9%
|
14
60.9%
|
50
65.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
9
17%
|
8
34.8%
|
17
22.4%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
53
100%
|
23
100%
|
76
100%
|
Outcome Measures
| Title | Number of Participants With Progression at the 3 Month Follow up Visit |
|---|---|
| Description | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Results below list the number of participants who progressed at the 3 month follow up visit |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) |
|---|---|---|
| Arm/Group Description | No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks |
| Measure Participants | 53 | 23 |
| Number [participants] |
15
28.3%
|
7
30.4%
|
| Title | Duration of Event Free Survival of Subjects Treated With Cabazitaxel |
|---|---|
| Description | To examine other measures of efficacy such as overall progression free in all evaluable patients |
| Time Frame | From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) |
|---|---|---|
| Arm/Group Description | No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks |
| Measure Participants | 53 | 23 |
| Median (95% Confidence Interval) [months] |
2.17
|
1.31
|
| Title | Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes |
|---|---|
| Description | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Time Frame | From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) |
|---|---|---|
| Arm/Group Description | No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks |
| Measure Participants | 53 | 22 |
| Stable Disease |
12
22.6%
|
5
21.7%
|
| Partial Response |
5
9.4%
|
3
13%
|
| Complete Response |
1
1.9%
|
0
0%
|
| Progression Disease |
34
64.2%
|
14
60.9%
|
| Death |
1
1.9%
|
0
0%
|
| Title | Percent of Participants Treated With Cabazitaxel With Event Free Survival |
|---|---|
| Description | To examine other measures of efficacy such as overall survival in all evaluable patients |
| Time Frame | From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) |
|---|---|---|
| Arm/Group Description | No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks |
| Measure Participants | 53 | 23 |
| Number (95% Confidence Interval) [percentage of participants] |
11.32
21.4%
|
13
56.5%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) | ||
| Arm/Group Description | No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks Cabazitaxel: 20mg IV over 1 hour every 3 weeks | ||
All Cause Mortality |
||||
| Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/53 (50.9%) | 15/23 (65.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Cardiac disorders | ||||
| Heart Block | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal Pain | 2/53 (3.8%) | 2 | 1/23 (4.3%) | 1 |
| Ascites | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Constipation | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Diarrhea | 2/53 (3.8%) | 2 | 0/23 (0%) | 0 |
| Dysphagia | 2/53 (3.8%) | 2 | 0/23 (0%) | 0 |
| Gastric Hemorrhage | 1/53 (1.9%) | 1 | 1/23 (4.3%) | 1 |
| Gastric perforation | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Right Upper Quadrant Pain | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| General disorders | ||||
| Death | 0/53 (0%) | 0 | 2/23 (8.7%) | 2 |
| Fatigue | 2/53 (3.8%) | 2 | 0/23 (0%) | 0 |
| Hypokalemia | 1/53 (1.9%) | 1 | 1/23 (4.3%) | 1 |
| Increased generalized weakness | 1/53 (1.9%) | 1 | 1/23 (4.3%) | 1 |
| Nausea | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Pain | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Infections and infestations | ||||
| Bacteremia | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Pneumonia | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Sepsis | 3/53 (5.7%) | 3 | 0/23 (0%) | 0 |
| Urinary Tract Infection | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Investigations | ||||
| Decreased white blood cell count | 4/53 (7.5%) | 5 | 3/23 (13%) | 3 |
| Neutropenia | 6/53 (11.3%) | 6 | 8/23 (34.8%) | 9 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/53 (3.8%) | 2 | 1/23 (4.3%) | 1 |
| Hypocalcemia | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Hyponatremia | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumor pain | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Nervous system disorders | ||||
| Stroke | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute Kidney Failure | 0/53 (0%) | 0 | 1/23 (4.3%) | 2 |
| Hematuria | 2/53 (3.8%) | 2 | 0/23 (0%) | 0 |
| Renal Failure | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Urinary Tract Obstruction | 1/53 (1.9%) | 1 | 1/23 (4.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural Effusion | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Pneumonitis | 1/53 (1.9%) | 1 | 0/23 (0%) | 0 |
| Shortness of Breath | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Vascular disorders | ||||
| Hypotension | 0/53 (0%) | 0 | 1/23 (4.3%) | 1 |
| Thromboembolic event | 0/53 (0%) | 0 | 2/23 (8.7%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| Arm A (Taxane naïve) | Arm B (Prior Taxane Therapy) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 53/53 (100%) | 27/27 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 25/53 (47.2%) | 34 | 13/27 (48.1%) | 19 |
| Disseminated intravascular coagulation | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Febrile neutropenia | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Leuocytosis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Lymphadenopathy | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Left Neck Adenopathy | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Myelosuppression | 2/53 (3.8%) | 2 | 1/27 (3.7%) | 1 |
| Cardiac disorders | ||||
| Cardiac arrest | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| tachycardia | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Complete heart block | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Heart Disease (Organic) | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Palpitations | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Hearing impaired | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| sound in ear | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Endocrine disorders | ||||
| Hypothyroidism | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Eye disorders | ||||
| Blurred vision | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Glaucoma | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| erythema at the bottom of eyelids | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| increased tears | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| vision change | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Right eye Pressure | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| right eye dimness | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal distension | 4/53 (7.5%) | 4 | 6/27 (22.2%) | 8 |
| Abdominal pain | 25/53 (47.2%) | 27 | 9/27 (33.3%) | 13 |
| Ascites | 6/53 (11.3%) | 6 | 5/27 (18.5%) | 6 |
| Bloating | 7/53 (13.2%) | 7 | 1/27 (3.7%) | 1 |
| Colitis | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Constipation | 16/53 (30.2%) | 20 | 8/27 (29.6%) | 10 |
| Diarrhea | 14/53 (26.4%) | 20 | 9/27 (33.3%) | 9 |
| Dry mouth | 3/53 (5.7%) | 3 | 0/27 (0%) | 0 |
| Dyspepsia | 3/53 (5.7%) | 3 | 3/27 (11.1%) | 3 |
| Dysphagia | 13/53 (24.5%) | 16 | 2/27 (7.4%) | 3 |
| Esophageal fistula | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Esophageal pain | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Flatulence | 0/53 (0%) | 0 | 2/27 (7.4%) | 4 |
| Gastric hemorrhage | 2/53 (3.8%) | 2 | 2/27 (7.4%) | 2 |
| Gastric perforation | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Gastric ulcer | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Gastritis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Gastroesophageal reflux disease | 8/53 (15.1%) | 9 | 0/27 (0%) | 0 |
| Gastrointestinal pain | 2/53 (3.8%) | 3 | 1/27 (3.7%) | 2 |
| Mucositis oral | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Nausea | 24/53 (45.3%) | 31 | 12/27 (44.4%) | 16 |
| Rectal Obstruction | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Stomach pain | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Vomiting | 13/53 (24.5%) | 18 | 9/27 (33.3%) | 13 |
| Increased Eructation | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Heartburn | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pain in anterior ribs | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hernia | 2/53 (3.8%) | 3 | 0/27 (0%) | 0 |
| mouth sore | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| hiatus hernia syndrome | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Increasing Epigastric Pain | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| early satiety | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| difficulty swallowing | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| pyloric stenosis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| early satiety | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| left upper quadrant pain | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| extensive peritoneal carcinomatosis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| H.Pylori Infection | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| increase sputum production | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| bloody stools | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hypercholesterolemia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Melena (black feces) | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Epigastric discomfort | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Abdominal Tenderness | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| epigastralgia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| oral thrush | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Anasarca | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Mouth ulcer | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Clostridium difficle | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Loose Stools | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Increased Abdominal Girth | 0/53 (0%) | 0 | 2/27 (7.4%) | 2 |
| Right Upper Quadrant Pain | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Anal fissure | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| burping | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Chills | 9/53 (17%) | 11 | 1/27 (3.7%) | 1 |
| Edema limbs | 9/53 (17%) | 11 | 7/27 (25.9%) | 7 |
| Fatigue | 47/53 (88.7%) | 64 | 19/27 (70.4%) | 26 |
| Fever | 4/53 (7.5%) | 5 | 2/27 (7.4%) | 3 |
| Localized edema | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Malaise | 4/53 (7.5%) | 4 | 1/27 (3.7%) | 1 |
| Non-cardiac chest pain | 2/53 (3.8%) | 2 | 1/27 (3.7%) | 1 |
| Rigors | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Big white light and dizziness | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| intermittent low appetite | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Lightheadedness | 1/53 (1.9%) | 1 | 2/27 (7.4%) | 2 |
| Weakness | 2/53 (3.8%) | 2 | 2/27 (7.4%) | 2 |
| Dizziness | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Edema- Scrotal | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Rash on Neck | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| neuropathy to fingers | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Weight Change | 2/53 (3.8%) | 2 | 1/27 (3.7%) | 1 |
| Skin Changes | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Body aches | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| hiatal hernia | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Hypokalemia | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Elevated CEA | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| cold intolerance | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Flu like symptoms | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Infusion related reaction | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Infusion site extravasation | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| uremia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| dehydration | 1/53 (1.9%) | 2 | 0/27 (0%) | 0 |
| Itching | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Abrasion on R forearm after CT Scan | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Anorexia | 3/53 (5.7%) | 4 | 0/27 (0%) | 0 |
| hypersensitivity to oxaliplatin | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| vasogenic edema | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| BLE Edema | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| moon face | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Headache | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Hypocalcemia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| HIGH ALKALINE PHOSPHATASE | 3/53 (5.7%) | 4 | 0/27 (0%) | 0 |
| HYPOALBUMINEMIA | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| general discomfort | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Neuropathy to Extremities | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Cold | 2/53 (3.8%) | 3 | 0/27 (0%) | 0 |
| Swelling from Contrast Dye | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Discharge from Feeding Tube | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Ascites | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| biopsy site sore and numb | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Night Sweats | 1/53 (1.9%) | 2 | 0/27 (0%) | 0 |
| arthralgia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| myalgia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| abdominal cramping | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Thrush | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholecystitis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Elevate Liver Functions | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Splenic Vein Thrombosis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| mild jaundice | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Immune system disorders | ||||
| Allergic reaction | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Allergy to Penecillin | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Infections and infestations | ||||
| flu | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Thrush | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| pneumonia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Sepsis | 4/53 (7.5%) | 4 | 1/27 (3.7%) | 1 |
| Urinary tract infection | 3/53 (5.7%) | 3 | 0/27 (0%) | 0 |
| Mycoplasma pneumoniae | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Acinetobacter baumanii bacteremia | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Positive blood culture | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Bacteruria | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fall | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Rib Pain (left side) | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| BRUISING | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Investigations | ||||
| decreseaed neutrophill count | 3/53 (5.7%) | 4 | 3/27 (11.1%) | 4 |
| Elevated ANC | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| decreased absolute lymphocyte count | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| decreased platelets | 5/53 (9.4%) | 8 | 1/27 (3.7%) | 2 |
| decreased WBC count | 9/53 (17%) | 14 | 7/27 (25.9%) | 10 |
| Weight gain | 9/53 (17%) | 10 | 0/27 (0%) | 0 |
| Weight loss | 0/53 (0%) | 0 | 3/27 (11.1%) | 3 |
| Metabolism and nutrition disorders | ||||
| Hyponatremia | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Early Satiety | 2/53 (3.8%) | 2 | 1/27 (3.7%) | 1 |
| Dysguesia | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Poor Appetite | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Hypoalbuminemia | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| hyperlipidemia | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Poor Oral Intake | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Decreased Appetite | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Hypophosphatemia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Obesity | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| vitamin B12 defeciency | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Iron defeciency | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Vitamin D3 defeciency | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Vitamin D deficiency | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| hypercholesterolemia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Diabetes | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hypercholesteremias | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Difficulty Feeding | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Dyspepsia | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| right upper quadrant pain | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Lower extremity chills at night | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pain in extremity | 3/53 (5.7%) | 4 | 0/27 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| bone metastasis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| shallow white-based ulcer on L Lower buccal mucosa near border of lip | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| new left cervical and supraclavicular adenopathy of the axilla | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Brain Metastases | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Tumor pain | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Bone Mets | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Nervous system disorders | ||||
| Concentration impairment | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Dizziness | 4/53 (7.5%) | 4 | 4/27 (14.8%) | 4 |
| Dysgeusia | 5/53 (9.4%) | 5 | 1/27 (3.7%) | 1 |
| Headache | 2/53 (3.8%) | 2 | 1/27 (3.7%) | 3 |
| Lightheadedness | 0/53 (0%) | 0 | 1/27 (3.7%) | 2 |
| balance difficulty | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| generalized weakness | 0/53 (0%) | 0 | 2/27 (7.4%) | 2 |
| hypersensitivity | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Neuropathy | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Paresthesia | 5/53 (9.4%) | 8 | 2/27 (7.4%) | 2 |
| Peripheral sensory neuropathy | 16/53 (30.2%) | 20 | 7/27 (25.9%) | 9 |
| reduced dexterity (right hand) | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Neuropathy | 3/53 (5.7%) | 3 | 0/27 (0%) | 0 |
| brain metastases | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| right arm spasms | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| TINGLING IN HANDS | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| vocal chord paralysis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Peripheral motor neuropathy | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Stroke | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Psychiatric disorders | ||||
| Agitation | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Anxiety | 14/53 (26.4%) | 14 | 5/27 (18.5%) | 5 |
| Depression | 7/53 (13.2%) | 7 | 2/27 (7.4%) | 2 |
| Insomnia | 8/53 (15.1%) | 8 | 5/27 (18.5%) | 6 |
| Hallucinations | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Apathy | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Altered Mental Status | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| night sweats | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 3/53 (5.7%) | 3 | 0/27 (0%) | 0 |
| Chronic kidney disease | 1/53 (1.9%) | 2 | 0/27 (0%) | 0 |
| Cystitis noninfective | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Hematuria | 12/53 (22.6%) | 18 | 2/27 (7.4%) | 4 |
| Hemoglobinuria | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pyuria | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hydronephrosis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Dysuria | 1/53 (1.9%) | 1 | 3/27 (11.1%) | 5 |
| Nocturia | 2/53 (3.8%) | 2 | 1/27 (3.7%) | 1 |
| overactive bladder | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| UROSEPSIS | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Hydronephrosis | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| left ureteral stricture | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| renal failure | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| decreased urine output | 1/53 (1.9%) | 1 | 1/27 (3.7%) | 1 |
| Proteinuria | 3/53 (5.7%) | 4 | 1/27 (3.7%) | 1 |
| Urinary frequency | 6/53 (11.3%) | 6 | 3/27 (11.1%) | 3 |
| Urinary incontinence | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Urinary retention | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Urinary tract obstruction | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Urinary tract pain | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Prostatitis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Bengin enlargement of Prostate | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Nephrolithiasis (Kidney Stone) | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Hydrouretroneprosis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| benign prostatic hypertrophy | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| urosepsis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Hydronephrosis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Renal Failure | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Difficulty Urinating | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Urinary tract obstruction | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Dysmenorrhea | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| increase in size of right testis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| post menopausal vaginal bleeding | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Vaginal hemorrhage | 1/53 (1.9%) | 2 | 0/27 (0%) | 0 |
| Aspiration | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Atelectasis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Cough | 6/53 (11.3%) | 8 | 4/27 (14.8%) | 4 |
| Dyspnea | 11/53 (20.8%) | 13 | 6/27 (22.2%) | 9 |
| Hiccups | 3/53 (5.7%) | 3 | 1/27 (3.7%) | 1 |
| Hoarseness | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Hypoxia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pneumonia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pulmonary embolism | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| rales at the bases | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| COPD exacerbation | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| increase mucus production | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| increased mucus | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Decreased breathing sounds over Left Lower Lung Field | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Shortness of Breath | 3/53 (5.7%) | 3 | 0/27 (0%) | 0 |
| Pleural effusion | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Pneumonitis | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Postnasal drip | 1/53 (1.9%) | 2 | 0/27 (0%) | 0 |
| Sleep apnea | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Allergic rhinitis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Epistaxis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Nasal congestion | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Shortness of Breath | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| VATS pleurodesis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Reproductive system and breast disorders | ||||
| increase in size of right testis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| post menopausal vaginal bleeding | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Vaginal hemorrhage | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis (nose bleeds) | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Allergic rhinitis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Cough | 6/53 (11.3%) | 8 | 4/27 (14.8%) | 4 |
| Dyspnea | 11/53 (20.8%) | 13 | 6/27 (22.2%) | 9 |
| Epistaxis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Hiccups | 3/53 (5.7%) | 3 | 1/27 (3.7%) | 1 |
| Nasal congestion | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Shortness of Breath | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| VATS pleurodesis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Pleural effusion | 0/53 (0%) | 0 | 2/27 (7.4%) | 2 |
| Pneumonitis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Sore throat | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Aspiration | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Atelectasis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hoarseness | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Hypoxia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pneumonia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pulmonary embolism | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| rales at the bases | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| COPD exacerbation | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| increase mucus production | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Decreased breathing sounds over Left Lower Lung Field | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Shortness of Breath | 3/53 (5.7%) | 3 | 0/27 (0%) | 0 |
| Pleural effusion | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Pneumonitis | 2/53 (3.8%) | 2 | 0/27 (0%) | 0 |
| Postnasal drip | 1/53 (1.9%) | 2 | 0/27 (0%) | 0 |
| Sleep apnea | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 6/53 (11.3%) | 6 | 2/27 (7.4%) | 2 |
| Dry skin | 2/53 (3.8%) | 2 | 2/27 (7.4%) | 4 |
| eczemarous dermatitis with eosinophilic folliculitis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Pruritic maculaopapular rash LUQ | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| rosacia | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Chills/ Sweats | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| psoriasis flare | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Puncture Wound Foot | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Skin Changes | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| ecchymotic rash on hands | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Darkening of skin surrounding nasal areas | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hyperhidrosis | 0/53 (0%) | 0 | 1/27 (3.7%) | 4 |
| Hypohidrosis | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Nail discoloration | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| slow skin turgor | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Rash | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| flushing | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Nodular findings | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
| Vascular disorders | ||||
| Flushing | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Hypertension | 5/53 (9.4%) | 7 | 2/27 (7.4%) | 2 |
| peripheral vascular disease | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| scatter petechiae | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| bloody nose | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Syncope | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| portal vein thrombosis | 1/53 (1.9%) | 1 | 0/27 (0%) | 0 |
| Thromboembolic event | 4/53 (7.5%) | 4 | 2/27 (7.4%) | 2 |
| Hypotension | 0/53 (0%) | 0 | 4/27 (14.8%) | 4 |
| easy bruisability | 0/53 (0%) | 0 | 1/27 (3.7%) | 1 |
Limitations/Caveats
[Not Specified]
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 | Navjot Kaur, GI Program Manager |
|---|---|
| Organization | Weill Cornell Medical College |
| Phone | 646-962-9350 |
| nak2028@med.cornell.edu |
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01757171
Other Study ID Numbers:
- 1208012946
First Posted:
Dec 28, 2012
Last Update Posted:
Apr 3, 2018
Last Verified:
Mar 1, 2018