Trial Outcomes & Findings for Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma (NCT NCT01757171)
NCT ID: NCT01757171
Last Updated: 2018-04-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
3 months
Results posted on
2018-04-03
Participant Flow
Participant milestones
| Measure |
Arm A (Taxane naïve)
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 (Prior Taxane Therapy)
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
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
24
|
|
Overall Study
COMPLETED
|
53
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Taxane naïve)
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 (Prior Taxane Therapy)
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Disease Progression
|
1
|
0
|
|
Overall Study
Hospitalization
|
1
|
0
|
|
Overall Study
ECOG decline
|
1
|
0
|
Baseline Characteristics
Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Arm A (Taxane naïve)
n=53 Participants
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 (Prior Taxane Therapy)
n=23 Participants
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
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
n=5 Participants
|
57.34 years
n=7 Participants
|
61.67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsProgression 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
Outcome measures
| Measure |
Arm A (Taxane naïve)
n=53 Participants
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 (Prior Taxane Therapy)
n=23 Participants
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
|
|---|---|---|
|
Number of Participants With Progression at the 3 Month Follow up Visit
|
15 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 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 monthsTo examine other measures of efficacy such as overall progression free in all evaluable patients
Outcome measures
| Measure |
Arm A (Taxane naïve)
n=53 Participants
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 (Prior Taxane Therapy)
n=23 Participants
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
|
|---|---|---|
|
Duration of Event Free Survival of Subjects Treated With Cabazitaxel
|
2.17 months
Interval 1.31 to 2.6
|
1.31 months
Interval 1.15 to 3.98
|
SECONDARY outcome
Timeframe: 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 monthsPer 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
Outcome measures
| Measure |
Arm A (Taxane naïve)
n=53 Participants
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 (Prior Taxane Therapy)
n=22 Participants
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
|
|---|---|---|
|
Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes
Stable Disease
|
12 participants
|
5 participants
|
|
Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes
Partial Response
|
5 participants
|
3 participants
|
|
Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes
Complete Response
|
1 participants
|
0 participants
|
|
Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes
Progression Disease
|
34 participants
|
14 participants
|
|
Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes
Death
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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 monthsTo examine other measures of efficacy such as overall survival in all evaluable patients
Outcome measures
| Measure |
Arm A (Taxane naïve)
n=53 Participants
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 (Prior Taxane Therapy)
n=23 Participants
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
|
|---|---|---|
|
Percent of Participants Treated With Cabazitaxel With Event Free Survival
|
11.32 percentage of participants
Interval 4.0 to 23.0
|
13 percentage of participants
Interval 3.0 to 34.0
|
Adverse Events
Arm A (Taxane naïve)
Serious events: 27 serious events
Other events: 53 other events
Deaths: 0 deaths
Arm B (Prior Taxane Therapy)
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Taxane naïve)
n=53 participants at risk
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 (Prior Taxane Therapy)
n=27 participants at risk；n=23 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/53
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.8%
2/53 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Acute Kidney Failure
|
0.00%
0/53
|
4.3%
1/23 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Bacteremia
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Decreased white blood cell count
|
7.5%
4/53 • Number of events 5
|
13.0%
3/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
2/53 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
2/53 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
2/53 • Number of events 2
|
0.00%
0/23
|
|
General disorders
Fatigue
|
3.8%
2/53 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
1.9%
1/53 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Heart Block
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Hypokalemia
|
1.9%
1/53 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Increased generalized weakness
|
1.9%
1/53 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Nausea
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Investigations
Neutropenia
|
11.3%
6/53 • Number of events 6
|
34.8%
8/23 • Number of events 9
|
|
Renal and urinary disorders
Hematuria
|
3.8%
2/53 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastric perforation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
General disorders
Pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Renal and urinary disorders
Renal Failure
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Right Upper Quadrant Pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Sepsis
|
5.7%
3/53 • Number of events 3
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/53
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Stroke
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/53
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.9%
1/53 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
Other adverse events
| Measure |
Arm A (Taxane naïve)
n=53 participants at risk
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 (Prior Taxane Therapy)
n=27 participants at risk；n=23 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.2%
25/53 • Number of events 34
|
48.1%
13/27 • Number of events 19
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Leuocytosis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Left Neck Adenopathy
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis (nose bleeds)
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
Myelosuppression
|
3.8%
2/53 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
tachycardia
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Cardiac disorders
Complete heart block
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
Heart Disease (Organic)
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
Palpitations
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Ear and labyrinth disorders
sound in ear
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Eye disorders
Blurred vision
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Eye disorders
Glaucoma
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
erythema at the bottom of eyelids
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
increased tears
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Eye disorders
vision change
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
Right eye Pressure
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
right eye dimness
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
4/53 • Number of events 4
|
22.2%
6/27 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
47.2%
25/53 • Number of events 27
|
33.3%
9/27 • Number of events 13
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Bloating
|
13.2%
7/53 • Number of events 7
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Constipation
|
30.2%
16/53 • Number of events 20
|
29.6%
8/27 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
26.4%
14/53 • Number of events 20
|
33.3%
9/27 • Number of events 9
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
3/53 • Number of events 3
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
3/53 • Number of events 3
|
11.1%
3/27 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
24.5%
13/53 • Number of events 16
|
7.4%
2/27 • Number of events 3
|
|
Gastrointestinal disorders
Esophageal fistula
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Esophageal pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/53
|
7.4%
2/27 • Number of events 4
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.8%
2/53 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Gastric perforation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.1%
8/53 • Number of events 9
|
0.00%
0/27
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.8%
2/53 • Number of events 3
|
3.7%
1/27 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
45.3%
24/53 • Number of events 31
|
44.4%
12/27 • Number of events 16
|
|
Gastrointestinal disorders
Rectal Obstruction
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
13/53 • Number of events 18
|
33.3%
9/27 • Number of events 13
|
|
Gastrointestinal disorders
Increased Eructation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Heartburn
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Pain in anterior ribs
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Hernia
|
3.8%
2/53 • Number of events 3
|
0.00%
0/27
|
|
Gastrointestinal disorders
mouth sore
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
hiatus hernia syndrome
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Increasing Epigastric Pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
early satiety
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
difficulty swallowing
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
pyloric stenosis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
left upper quadrant pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
extensive peritoneal carcinomatosis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
H.Pylori Infection
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
increase sputum production
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
bloody stools
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Hypercholesterolemia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Melena (black feces)
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
epigastralgia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
oral thrush
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Anasarca
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulcer
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Clostridium difficle
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Loose Stools
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Increased Abdominal Girth
|
0.00%
0/53
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Right Upper Quadrant Pain
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
burping
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Chills
|
17.0%
9/53 • Number of events 11
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Edema limbs
|
17.0%
9/53 • Number of events 11
|
25.9%
7/27 • Number of events 7
|
|
Gastrointestinal disorders
Fatigue
|
88.7%
47/53 • Number of events 64
|
70.4%
19/27 • Number of events 26
|
|
Gastrointestinal disorders
Fever
|
7.5%
4/53 • Number of events 5
|
7.4%
2/27 • Number of events 3
|
|
Gastrointestinal disorders
Localized edema
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Malaise
|
7.5%
4/53 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Non-cardiac chest pain
|
3.8%
2/53 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Rigors
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Big white light and dizziness
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
intermittent low appetite
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Lightheadedness
|
1.9%
1/53 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Weakness
|
3.8%
2/53 • Number of events 2
|
7.4%
2/27 • Number of events 2
|
|
Gastrointestinal disorders
Dizziness
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Edema- Scrotal
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Rash on Neck
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
neuropathy to fingers
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Weight Change
|
3.8%
2/53 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Skin Changes
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Body aches
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
hiatal hernia
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Hypokalemia
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Elevated CEA
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
cold intolerance
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Flu like symptoms
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Infusion related reaction
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Infusion site extravasation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
uremia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
dehydration
|
1.9%
1/53 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Itching
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abrasion on R forearm after CT Scan
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Anorexia
|
5.7%
3/53 • Number of events 4
|
0.00%
0/27
|
|
Gastrointestinal disorders
hypersensitivity to oxaliplatin
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
vasogenic edema
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
BLE Edema
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
moon face
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Headache
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
Hypocalcemia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
HIGH ALKALINE PHOSPHATASE
|
5.7%
3/53 • Number of events 4
|
0.00%
0/27
|
|
Gastrointestinal disorders
HYPOALBUMINEMIA
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
general discomfort
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Neuropathy to Extremities
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Cold
|
3.8%
2/53 • Number of events 3
|
0.00%
0/27
|
|
Gastrointestinal disorders
Swelling from Contrast Dye
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Discharge from Feeding Tube
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
biopsy site sore and numb
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Night Sweats
|
1.9%
1/53 • Number of events 2
|
0.00%
0/27
|
|
Gastrointestinal disorders
arthralgia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
myalgia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
abdominal cramping
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Thrush
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Hepatobiliary disorders
Elevate Liver Functions
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Hepatobiliary disorders
Splenic Vein Thrombosis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Hepatobiliary disorders
mild jaundice
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Immune system disorders
Allergy to Penecillin
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
flu
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
Thrush
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
pneumonia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
Sepsis
|
7.5%
4/53 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.7%
3/53 • Number of events 3
|
0.00%
0/27
|
|
Infections and infestations
Mycoplasma pneumoniae
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Acinetobacter baumanii bacteremia
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Positive blood culture
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Bacteruria
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Rib Pain (left side)
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
BRUISING
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Investigations
decreseaed neutrophill count
|
5.7%
3/53 • Number of events 4
|
11.1%
3/27 • Number of events 4
|
|
Investigations
Elevated ANC
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Investigations
decreased absolute lymphocyte count
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Investigations
decreased platelets
|
9.4%
5/53 • Number of events 8
|
3.7%
1/27 • Number of events 2
|
|
Investigations
decreased WBC count
|
17.0%
9/53 • Number of events 14
|
25.9%
7/27 • Number of events 10
|
|
Investigations
Weight gain
|
17.0%
9/53 • Number of events 10
|
0.00%
0/27
|
|
Investigations
Weight loss
|
0.00%
0/53
|
11.1%
3/27 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Early Satiety
|
3.8%
2/53 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Dysguesia
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Poor Appetite
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperlipidemia
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Poor Oral Intake
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Obesity
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
vitamin B12 defeciency
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Iron defeciency
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Vitamin D3 defeciency
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Diabetes
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Hypercholesteremias
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Difficulty Feeding
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Dyspepsia
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
right upper quadrant pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Lower extremity chills at night
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
3/53 • Number of events 4
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bone metastasis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
shallow white-based ulcer on L Lower buccal mucosa near border of lip
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
new left cervical and supraclavicular adenopathy of the axilla
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Metastases
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Mets
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • Number of events 4
|
14.8%
4/27 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
9.4%
5/53 • Number of events 5
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.8%
2/53 • Number of events 2
|
3.7%
1/27 • Number of events 3
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/53
|
3.7%
1/27 • Number of events 2
|
|
Nervous system disorders
balance difficulty
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
generalized weakness
|
0.00%
0/53
|
7.4%
2/27 • Number of events 2
|
|
Nervous system disorders
hypersensitivity
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
5.7%
3/53 • Number of events 3
|
0.00%
0/27
|
|
Nervous system disorders
Paresthesia
|
9.4%
5/53 • Number of events 8
|
7.4%
2/27 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.2%
16/53 • Number of events 20
|
25.9%
7/27 • Number of events 9
|
|
Nervous system disorders
reduced dexterity (right hand)
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
brain metastases
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
right arm spasms
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
TINGLING IN HANDS
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
vocal chord paralysis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Nervous system disorders
Stroke
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Agitation
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
26.4%
14/53 • Number of events 14
|
18.5%
5/27 • Number of events 5
|
|
Psychiatric disorders
Depression
|
13.2%
7/53 • Number of events 7
|
7.4%
2/27 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
15.1%
8/53 • Number of events 8
|
18.5%
5/27 • Number of events 6
|
|
Psychiatric disorders
Hallucinations
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Apathy
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Altered Mental Status
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
night sweats
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Acute kidney injury
|
5.7%
3/53 • Number of events 3
|
0.00%
0/27
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.9%
1/53 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
22.6%
12/53 • Number of events 18
|
7.4%
2/27 • Number of events 4
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Pyuria
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/53 • Number of events 1
|
11.1%
3/27 • Number of events 5
|
|
Renal and urinary disorders
Nocturia
|
3.8%
2/53 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
overactive bladder
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
UROSEPSIS
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
left ureteral stricture
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
renal failure
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
decreased urine output
|
1.9%
1/53 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
5.7%
3/53 • Number of events 4
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
11.3%
6/53 • Number of events 6
|
11.1%
3/27 • Number of events 3
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Prostatitis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Bengin enlargement of Prostate
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis (Kidney Stone)
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Hydrouretroneprosis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
benign prostatic hypertrophy
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
urosepsis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Difficulty Urinating
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Dysmenorrhea
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
increase in size of right testis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
post menopausal vaginal bleeding
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Vaginal hemorrhage
|
1.9%
1/53 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Aspiration
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Atelectasis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Cough
|
11.3%
6/53 • Number of events 8
|
14.8%
4/27 • Number of events 4
|
|
Renal and urinary disorders
Dyspnea
|
20.8%
11/53 • Number of events 13
|
22.2%
6/27 • Number of events 9
|
|
Renal and urinary disorders
Hiccups
|
5.7%
3/53 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Hoarseness
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Hypoxia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Pneumonia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Pulmonary embolism
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
rales at the bases
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
COPD exacerbation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
increase mucus production
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
increased mucus
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Decreased breathing sounds over Left Lower Lung Field
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Shortness of Breath
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Pleural effusion
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Pneumonitis
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Postnasal drip
|
1.9%
1/53 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Sleep apnea
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Allergic rhinitis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Epistaxis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Nasal congestion
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
VATS pleurodesis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Reproductive system and breast disorders
increase in size of right testis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Reproductive system and breast disorders
post menopausal vaginal bleeding
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
6/53 • Number of events 8
|
14.8%
4/27 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.8%
11/53 • Number of events 13
|
22.2%
6/27 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.7%
3/53 • Number of events 3
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
5.7%
3/53 • Number of events 3
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
VATS pleurodesis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
rales at the bases
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
increase mucus production
|
3.8%
2/53 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breathing sounds over Left Lower Lung Field
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.9%
1/53 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.3%
6/53 • Number of events 6
|
7.4%
2/27 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
2/53 • Number of events 2
|
7.4%
2/27 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
eczemarous dermatitis with eosinophilic folliculitis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Pruritic maculaopapular rash LUQ
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
rosacia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Chills/ Sweats
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
psoriasis flare
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Puncture Wound Foot
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Skin Changes
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
ecchymotic rash on hands
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Darkening of skin surrounding nasal areas
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
slow skin turgor
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
flushing
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nodular findings
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
Hypertension
|
9.4%
5/53 • Number of events 7
|
7.4%
2/27 • Number of events 2
|
|
Vascular disorders
peripheral vascular disease
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
scatter petechiae
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
bloody nose
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
Syncope
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
portal vein thrombosis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/27
|
|
Vascular disorders
Thromboembolic event
|
7.5%
4/53 • Number of events 4
|
7.4%
2/27 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/53
|
14.8%
4/27 • Number of events 4
|
|
Vascular disorders
easy bruisability
|
0.00%
0/53
|
3.7%
1/27 • Number of events 1
|
Additional Information
Navjot Kaur, GI Program Manager
Weill Cornell Medical College
Phone: 646-962-9350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place