Trial Outcomes & Findings for A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (NCT NCT00876915)
NCT ID: NCT00876915
Last Updated: 2015-11-24
Results Overview
The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-11-24
Participant Flow
Participants screened for the study but deemed low or medium risk by Khorona scoring will be offered to consent to a one time baseline blood sample. These samples will be used as the control group to establish the value of TF as a predictive marker for VTE in ambulatory cancer patients as described in the Secondary Objectives.
Participants who undergo a baseline US/CT scan and are found to have a DVT/PE will be considered a screen failure and will not be randomized and continue on in the study. In addition, if any of the screening criteria are not met, these subjects will be considered screen failures.
Participant milestones
| Measure |
High Risk Dalteparin Injection
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
High Risk No Therapy
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
Low or Medium Risk Group
Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
101
|
|
Overall Study
Week 4
|
38
|
45
|
0
|
|
Overall Study
Week 8
|
33
|
36
|
0
|
|
Overall Study
COMPLETED
|
31
|
34
|
101
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
Baseline characteristics by cohort
| Measure |
High Risk Randomized to Dalteparin Injection
n=50 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
High Risk Randomized to No Therapy
n=48 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
Low Risk
n=101 Participants
Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
45 participants
n=7 Participants
|
101 participants
n=5 Participants
|
192 participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 10 • n=5 Participants
|
58 years
STANDARD_DEVIATION 12 • n=7 Participants
|
58 years
STANDARD_DEVIATION 13 • n=5 Participants
|
58 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.
Outcome measures
| Measure |
Dalteparin Injection
n=50 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=48 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
Percentage of Patients With Venous Thromboembolisms
|
12 percentage of participants
|
21 percentage of participants
|
PRIMARY outcome
Timeframe: 13 weeksThe percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma \> 25 cm², epistaxis \> 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding \> 5 mins, hemoptysis, hematemesis or prolonged bleeding (\> 5 minutes) after venipuncture.
Outcome measures
| Measure |
Dalteparin Injection
n=50 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=48 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
Percentage of Patients Who Experienced Clinically Significant Bleeding Events.
|
14 percentage of participants
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: baseline value of tissue factorPopulation: From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients.
Outcome measures
| Measure |
Dalteparin Injection
n=89 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=101 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
|
0.669 pg/mL
Standard Deviation 1.35
|
0.187 pg/mL
Standard Deviation 0.492
|
SECONDARY outcome
Timeframe: baseline value of D-DimerPopulation: From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Outcome measures
| Measure |
Dalteparin Injection
n=89 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=101 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
|
2.99 ug/mL
Standard Deviation 5.67
|
1.87 ug/mL
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: baseline value of Human F12Population: From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Outcome measures
| Measure |
Dalteparin Injection
n=89 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=101 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
|
484.7 ng/mL
Standard Deviation 1167.6
|
306.3 ng/mL
Standard Deviation 552.7
|
SECONDARY outcome
Timeframe: baseline value of TFPIPopulation: From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Outcome measures
| Measure |
Dalteparin Injection
n=89 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=101 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
|
813.6 pg/mL
Standard Deviation 391.3
|
738.2 pg/mL
Standard Deviation 351.1
|
SECONDARY outcome
Timeframe: baseline value of FVIIaPopulation: From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Outcome measures
| Measure |
Dalteparin Injection
n=89 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=101 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
|
151.2 pM
Standard Deviation 59.4
|
148.6 pM
Standard Deviation 92.2
|
SECONDARY outcome
Timeframe: baseline value of TATPopulation: From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.
Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients
Outcome measures
| Measure |
Dalteparin Injection
n=89 Participants
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=101 Participants
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients
|
9.89 ug/L
Standard Deviation 20.09
|
12.44 ug/L
Standard Deviation 21.42
|
Adverse Events
Dalteparin Injection
Serious events: 26 serious events
Other events: 39 other events
Deaths: 0 deaths
No Therapy
Serious events: 18 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalteparin Injection
n=50 participants at risk
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=48 participants at risk
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
alkaline phosphatase
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
ascites
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
anorexia
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
Cardiac Troponin T
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
bilirubin (hyperbilirubinemia)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Cholangitis-bilary tree stricture
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Social circumstances
Confusion
|
2.0%
1/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Creatinine
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Investigations
Death
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Dehydration
|
8.0%
4/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Encephalopathy
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
fatigue
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
febrile neutropenia
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Hepatobiliary disorders
Obstruction - biliary tree
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Glucose, serum - high (hyperglycemia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Glucose, serum - low (hypoglycemia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Reproductive system and breast disorders
Hemorrhage, GU - Vagina
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
Hypotension
|
8.0%
4/50 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Infection - Other (Sepsis)
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Infection - Lung (pneumonia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Infection - Other (Spontaneous Bacterial Peritonitis)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Infection - Other
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Infection - Other (skin cellulitis)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Infection with normal ANC
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Hepatobiliary disorders
Liver Dysfunction
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) - oral cavity
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Memory Impairment
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - whole body/generalized
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
Neurology - Other (altered mental status)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Neurology - Other (loss of consciousness)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Neurology - Other (pseudoseizures)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Neuropathy - motor
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
8.0%
4/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
Pain - chest/thorax NOS
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Pain - Anus
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
Pain - head/headache
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Pain - Esophagus
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
Pain - NOS
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Perforation, GI
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
Pneumonitis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Potassium, serum - high (hyperkalemia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
sodium, serum - low (hyponatremia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
Somnolence/depressed level of consciousness
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
Rigors/chills
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Vascular disorders
Thrombosis/Thrombus/embolism
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Ulcer, GI - Duodenum
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
Ventricular arrhythmia - ventricular tachycardia
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
weight loss
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
Other adverse events
| Measure |
Dalteparin Injection
n=50 participants at risk
Patients will be assigned at random to receive prophylactic dalteparin injections
dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
|
No Therapy
n=48 participants at risk
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
|
|---|---|---|
|
Metabolism and nutrition disorders
creatinine
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
dehydration
|
8.0%
4/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
diarrhea
|
18.0%
9/50 • Number of events 12 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
27.1%
13/48 • Number of events 15 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
dizziness
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
16.7%
8/48 • Number of events 8 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
distension/bloating, abdominal
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
dysphagia
|
8.0%
4/50 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea (shortness of breath)
|
8.0%
4/50 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
edema: limb
|
8.0%
4/50 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
edema: head and neck
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
edema
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
esophagitis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
fatigue
|
36.0%
18/50 • Number of events 18 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
43.8%
21/48 • Number of events 24 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
febrile neutropenia
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
fever
|
22.0%
11/50 • Number of events 12 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
flu-like symptoms
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
flushing
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Albumin, serum - low (hypoalbuminemia)
|
14.0%
7/50 • Number of events 7 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
16.7%
8/48 • Number of events 8 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
16.7%
8/48 • Number of events 9 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
allergic reaction/hypersensetivity
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
ALT
|
26.0%
13/50 • Number of events 13 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
20.8%
10/48 • Number of events 11 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
Anorexia
|
18.0%
9/50 • Number of events 9 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
25.0%
12/48 • Number of events 12 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
AST
|
18.0%
9/50 • Number of events 9 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
27.1%
13/48 • Number of events 16 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
bilirubin (hyperbilirubinemia)
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
blood - other (leukocytosis)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Injury, poisoning and procedural complications
bruising
|
10.0%
5/50 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
calcium, serum - high (hypercalcemia)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
calcium, serum - low (hypocalcemia)
|
16.0%
8/50 • Number of events 8 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
16.7%
8/48 • Number of events 8 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
confusion
|
6.0%
3/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
colitis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
constipation
|
26.0%
13/50 • Number of events 13 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
14.6%
7/48 • Number of events 8 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
10.0%
5/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
constitutional symptoms - other (cachexia)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
glucose, serum - high (hyperglycemia)
|
22.0%
11/50 • Number of events 11 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
20.8%
10/48 • Number of events 11 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
glucose, serum - low (hypoglycemia)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
gastrointestinal - incontinence, bowel
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
GI - other
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
GI - other (biliary tree obstruction)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
gastrointestinal - other (gas pain)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
heartburn/dyspepsia
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
hemoglobin
|
34.0%
17/50 • Number of events 21 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
41.7%
20/48 • Number of events 21 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
henorrhage, GI - Rectum
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
hemorrhage, pulmonary/upper respiratory - nose
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
hemorrhage, GI-Lower GI NOS
|
2.0%
1/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
hemorrhage, GI-upper GI NOS
|
2.0%
1/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
hiccoughs
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
hypertension
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
hypotension
|
10.0%
5/50 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Renal and urinary disorders
incontinence, urinary
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - conjunctiva
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - other (sinus)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - other
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - other (skin, cellulitis)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - other (thrush)
|
4.0%
2/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - other (urinary tract NOS)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection - other (upper respiratory)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection with grade 2 neutrophils - skin (cellulitis)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection with normal ANC
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection with normal ANC - bronchus
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
infection with unknown ANC
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
insomnia
|
8.0%
4/50 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
leukocytes (total WBC)
|
26.0%
13/50 • Number of events 13 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
29.2%
14/48 • Number of events 17 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Hepatobiliary disorders
liver dysfunction
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
lymphopenia
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
lymphatics - other (anasarca)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
magnesium, serum - low (hypomagnesemia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
memory impairment
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
nausea
|
40.0%
20/50 • Number of events 22 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
47.9%
23/48 • Number of events 25 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
neuropathy - sensory
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
31.2%
15/48 • Number of events 15 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
neurology - other (neuropraxia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
neutrophils/granulocytes (ANC/AGC)
|
20.0%
10/50 • Number of events 10 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
20.8%
10/48 • Number of events 11 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
obstruction - Gtube
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - abdomen NOS
|
16.0%
8/50 • Number of events 9 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
14.6%
7/48 • Number of events 7 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Blood and lymphatic system disorders
platelets
|
14.0%
7/50 • Number of events 7 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
20.8%
10/48 • Number of events 11 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
vomiting
|
14.0%
7/50 • Number of events 8 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
31.2%
15/48 • Number of events 17 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
weight loss
|
22.0%
11/50 • Number of events 11 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
20.8%
10/48 • Number of events 10 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
potassium, serum-high (hyperkalemia)
|
10.0%
5/50 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
potassium, serum-low (hypokalemia)
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
12.5%
6/48 • Number of events 7 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - chest/thorax NOS
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - back
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Renal and urinary disorders
pain - dysuria (painful urination)
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
pain - throat
|
10.0%
5/50 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - extremity - limb
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
pain - cardiac/chest
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - head/headache
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
pain - muscle
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Ear and labyrinth disorders
pain - other (ear)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - other (groin)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
pain - joint
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - other (jaw)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - NOS
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
pain - other (knee)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
pain - other (peg tube site)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
pain - skin
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
pain - stomach
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Vascular disorders
phlebitis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
pruritus/itching
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
psychosis (hallucinations/delusions)
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
rash: hand-foot skin reaction
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
rash: acne/acneiform
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
General disorders
rigors/chills
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 5 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
salivary gland changes/saliva
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
sodium, serum-high (hypernatremia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
skin breakdown (thighs)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
skin breakdown/decubitus ulcer
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
sodium, serum-low (hyponatremia)
|
10.0%
5/50 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
supraventricular arrythmia - sinus tachycardia
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Cardiac disorders
supraventricular arrythmia - atrial fibrillation
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
sweating (diaphoresis)
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
mood alteration - agitation
|
6.0%
3/50 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Metabolism and nutrition disorders
metabolic/laboratory - other (azotemia)
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
mood alteration - anxiety
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Psychiatric disorders
mood alteration - depression
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
mucositis (fuctional/symptomatic) - oral cavity
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
8.3%
4/48 • Number of events 4 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
dermatitis - chemoradiation
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
muscle weakness - whole body/generalized
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Nervous system disorders
syncope
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Endocrine disorders
syndromes - other (serotonergic syndrome)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Infections and infestations
syndromes - other (systemic inflammatory response syndrome (SIRS))
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
taste alteration (dysgeusia)
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
6.2%
3/48 • Number of events 3 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Musculoskeletal and connective tissue disorders
tremor
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Vascular disorders
thrombosis/thrombus/embolism
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
12.5%
6/48 • Number of events 6 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Gastrointestinal disorders
ulcer, GI - stomach
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Vascular disorders
vascular - thrombosis
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Renal and urinary disorders
urinary frequency/urgency
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
4.2%
2/48 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Skin and subcutaneous tissue disorders
ulceration
|
0.00%
0/50 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Renal and urinary disorders
urinary retention
|
2.0%
1/50 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
2.1%
1/48 • Number of events 1 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
4.0%
2/50 • Number of events 2 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
0.00%
0/48 • 13 weeks, 12 weeks on active treatment + 1 additional week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place