Trial Outcomes & Findings for Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer (NCT NCT02581215)
NCT ID: NCT02581215
Last Updated: 2025-01-01
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time of registration until disease progression met by RECIST 1.1 or death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
9 months
Results posted on
2025-01-01
Participant Flow
Participant milestones
| Measure |
Arm A: Experimental Arm
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm A: Experimental Arm
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Overall Study
Screen Failure Before Therapy Start
|
0
|
1
|
|
Overall Study
Eligibility Criteria Not Met
|
0
|
1
|
Baseline Characteristics
Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Experimental Arm
n=42 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=40 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
65 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
40 participants
n=107 Participants
|
82 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time of registration until disease progression met by RECIST 1.1 or death from any cause.
Outcome measures
| Measure |
Arm A: Experimental Arm
n=42 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=40 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Progression Free Survival (PFS) at 9 Month
|
25.1 Percentage of participants
Interval 11.6 to 41.3
|
35 Percentage of participants
Interval 19.8 to 50.6
|
SECONDARY outcome
Timeframe: Up to a maximum of 53 monthsOverall survival is defined by the date of randomization to date of death from any cause.
Outcome measures
| Measure |
Arm A: Experimental Arm
n=42 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=40 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
10.3 Months
Interval 6.0 to 11.8
|
9.7 Months
Interval 6.4 to 15.9
|
SECONDARY outcome
Timeframe: Up to 44 monthsPopulation: The analysis population for the endpoint Response Rate (RR) was defined as all participants with at least one post-baseline disease assessment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A: Experimental Arm
n=34 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=31 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Response Rate (RR)
|
17.7 Percentage of participants
|
22.6 Percentage of participants
|
SECONDARY outcome
Timeframe: From date of first dose until 30 days after the last treatment, assessed up to 44 monthsAdverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Outcome measures
| Measure |
Arm A: Experimental Arm
n=42 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=40 Participants
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
42 Participants
|
40 Participants
|
Adverse Events
Arm A: Experimental Arm
Serious events: 19 serious events
Other events: 41 other events
Deaths: 33 deaths
Arm B: Placebo Arm
Serious events: 17 serious events
Other events: 39 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Arm A: Experimental Arm
n=42 participants at risk
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=40 participants at risk
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
COLITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Psychiatric disorders
CONFUSION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
FATIGUE
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
GASTRITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
HYPOTENSION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
PAIN
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
SEPSIS
|
7.1%
3/42 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
SYNCOPE
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
VOMITING
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
BLADDER INFECTION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
DEATH NOS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Hepatobiliary disorders
HEPATOBILIARY DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
RENAL CALCULI
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACKS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
VISCERAL ARTERIAL ISCHEMIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
Other adverse events
| Measure |
Arm A: Experimental Arm
n=42 participants at risk
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Ramucirumab: Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
|
Arm B: Placebo Arm
n=40 participants at risk
mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab
mFOLFIRINOX: mFOLFIRINOX:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
Placebo: Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Immune system disorders
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
INR INCREASED
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ORAL DYSESTHESIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
PANCREATIC ENZYMES DECREASED
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
URINE DISCOLORATION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
47.6%
20/42 • Number of events 32 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
45.0%
18/40 • Number of events 28 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
7/42 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
17.5%
7/40 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
ABDOMINAL SOFT TISSUE NECROSIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
23.8%
10/42 • Number of events 19 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
15.0%
6/40 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
26.2%
11/42 • Number of events 23 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
25.0%
10/40 • Number of events 26 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Immune system disorders
ALLERGIC REACTION
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
17.5%
7/40 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
33.3%
14/42 • Number of events 44 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
30.0%
12/40 • Number of events 46 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
47.6%
20/42 • Number of events 33 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
40.0%
16/40 • Number of events 25 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Psychiatric disorders
ANXIETY
|
14.3%
6/42 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
22.5%
9/40 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
16.7%
7/42 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
BLOATING
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
11.9%
5/42 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Eye disorders
BLURRED VISION
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
CHILLS
|
4.8%
2/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
COLITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Psychiatric disorders
CONFUSION
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
26.2%
11/42 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
27.5%
11/40 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.9%
5/42 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
CREATININE INCREASED
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
19.0%
8/42 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
20.0%
8/40 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Psychiatric disorders
DEPRESSION
|
19.0%
8/42 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
69.0%
29/42 • Number of events 58 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
67.5%
27/40 • Number of events 56 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
DIZZINESS
|
11.9%
5/42 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DUODENAL PERFORATION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
DYSARTHRIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
DYSESTHESIA
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
7/42 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
9.5%
4/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
17.5%
7/40 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
EDEMA LIMBS
|
14.3%
6/42 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
9.5%
4/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL OBSTRUCTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Injury, poisoning and procedural complications
FALL
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
FATIGUE
|
66.7%
28/42 • Number of events 66 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
62.5%
25/40 • Number of events 54 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
FEVER
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
17.5%
7/40 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
GAIT DISTURBANCE
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
16.7%
7/42 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
20.0%
8/40 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
9.5%
4/42 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
14.3%
6/42 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
11.9%
5/42 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
GUM INFECTION
|
4.8%
2/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
HEADACHE
|
14.3%
6/42 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
2.4%
1/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
19.0%
8/42 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
22.5%
9/40 • Number of events 23 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
2.4%
1/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
HYPERTENSION
|
28.6%
12/42 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
25.0%
10/40 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
7.1%
3/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
16.7%
7/42 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
11.9%
5/42 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
31.0%
13/42 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
30.0%
12/40 • Number of events 31 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
19.0%
8/42 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
15.0%
6/40 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
21.4%
9/42 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
HYPOTENSION
|
4.8%
2/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
9.5%
4/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
INFUSION RELATED REACTION
|
7.1%
3/42 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Psychiatric disorders
INSOMNIA
|
9.5%
4/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
LYMPHEDEMA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
9.5%
4/42 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
MALABSORPTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
MUCOSAL INFECTION
|
4.8%
2/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
14.3%
6/42 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
NAUSEA
|
69.0%
29/42 • Number of events 70 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
70.0%
28/40 • Number of events 51 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
7.1%
3/42 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
40.5%
17/42 • Number of events 35 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
35.0%
14/40 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ORAL PAIN
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
PAIN
|
9.5%
4/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
PANCREATITIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
PARESTHESIA
|
9.5%
4/42 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
11.9%
5/42 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
50.0%
21/42 • Number of events 33 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
52.5%
21/40 • Number of events 42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
PERITONEAL INFECTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL MUCOSITIS
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
23.8%
10/42 • Number of events 45 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
32.5%
13/40 • Number of events 45 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
PRESYNCOPE
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
4.8%
2/42 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
RENAL CALCULI
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
RENAL COLIC
|
2.4%
1/42 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
SALIVARY DUCT INFLAMMATION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
SEPSIS
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
SINUS PAIN
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
10.0%
4/40 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
SINUSITIS
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
4.8%
2/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
11.9%
5/42 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
17.5%
7/40 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
TOOTH INFECTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
TREMOR
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
7.1%
3/42 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.5%
4/42 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
4.8%
2/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
VOMITING
|
54.8%
23/42 • Number of events 39 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
37.5%
15/40 • Number of events 37 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Eye disorders
WATERING EYES
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
WEIGHT GAIN
|
2.4%
1/42 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
WEIGHT LOSS
|
59.5%
25/42 • Number of events 30 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
45.0%
18/40 • Number of events 20 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
19.0%
8/42 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
12.5%
5/40 • Number of events 21 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
WOUND INFECTION
|
2.4%
1/42 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
0.00%
0/40 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Hepatobiliary disorders
HEPATOBILIARY DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
BLADDER INFECTION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Injury, poisoning and procedural complications
BRUISING
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Ear and labyrinth disorders
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
EDEMA TRUNK
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL ULCER
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Nervous system disorders
FACIAL MUSCLE WEAKNESS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
|
Vascular disorders
HEMATOMA
|
0.00%
0/42 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 53 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 44 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place