Trial Outcomes & Findings for Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer (NCT NCT01926197)
NCT ID: NCT01926197
Last Updated: 2022-10-28
Results Overview
Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
38 months
Results posted on
2022-10-28
Participant Flow
Participant milestones
| Measure |
Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Overall Study
Withdrawn to receive chemotherapy
|
1
|
0
|
|
Overall Study
Withdrawn due to non-coverage by insurance
|
0
|
1
|
Baseline Characteristics
Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Modified FOLFIRINOX
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
63 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 38 monthsProgression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Outcome measures
| Measure |
Modified FOLFIRINOX
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
6.5 months
Standard Deviation 6.6
|
8.4 months
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 38 monthsLocal progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation.
Outcome measures
| Measure |
Modified FOLFIRINOX
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Local Progression-free Survival (Local PFS)
|
6.5 months
Standard Deviation 6.6
|
8.4 months
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 1 yearProgression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment. The outcome is reported as a number without dispersion.
Outcome measures
| Measure |
Modified FOLFIRINOX
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Progression-free Survival (PFS) at 1 Year
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 62 monthsMetastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Outcome measures
| Measure |
Modified FOLFIRINOX
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Metastasis-free Survival (MFS)
|
12.9 months
Standard Deviation 6.4
|
10.8 months
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 62 monthsThe effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation.
Outcome measures
| Measure |
Modified FOLFIRINOX
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Overall Survival (OS)
|
12.9 months
Standard Deviation 6.4
|
13.4 months
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Analysis group is those participants that received at least one dose of the Modified FOLFIRINOX (mFFX) chemotherapy regimen.
Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is reported as numbers without dispersion. All-cause Mortality mFFX 7 SBRT 8
Outcome measures
| Measure |
Modified FOLFIRINOX
n=13 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=12 Participants
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Blood in stool (melena)
|
1 Related adverse events
|
0 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Colitis
|
1 Related adverse events
|
0 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Colonic obstruction
|
1 Related adverse events
|
0 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Diarrhea
|
3 Related adverse events
|
0 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Duodenal perforation
|
0 Related adverse events
|
1 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Fistula, anal
|
0 Related adverse events
|
3 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Fluid in abdomen (ascites)
|
0 Related adverse events
|
2 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Gastrointestinal bleed (hemorrhage)
|
1 Related adverse events
|
1 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Gastrointestinal bleed (hemorrhage), upper
|
0 Related adverse events
|
3 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Gastrointestinal inflammation (enterocolitis)
|
1 Related adverse events
|
0 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Nausea
|
3 Related adverse events
|
1 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Pain, abdominal
|
3 Related adverse events
|
4 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Pain, intractable (due to disease progression)
|
0 Related adverse events
|
1 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Stool discolored, clay color
|
1 Related adverse events
|
0 Related adverse events
|
|
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Vomited blood (hematemesis)
|
0 Related adverse events
|
4 Related adverse events
|
Adverse Events
Modified FOLFIRINOX
Serious events: 5 serious events
Other events: 12 other events
Deaths: 7 deaths
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
Serious events: 7 serious events
Other events: 13 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Modified FOLFIRINOX
n=12 participants at risk
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=13 participants at risk
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Other, hemoglobin decreased
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Pain, abdominal
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Bleed (hemorrhage), gastrointestinal
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Bleed (hemorrhage), gastrointestinal upper
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
General disorders
Pain, intractable (due to disease progression)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Infections and infestations
Lung infection - Klebsiella pneumonia
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Renal and urinary disorders
Other, renal failure
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
Other adverse events
| Measure |
Modified FOLFIRINOX
n=12 participants at risk
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
|
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
n=13 participants at risk
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
* Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
* Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
* 5FU: 5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
* Stereotactic Body Radiotherapy (SBRT): Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
10/12 • Number of events 88 • up to 62 months
|
84.6%
11/13 • Number of events 100 • up to 62 months
|
|
Blood and lymphatic system disorders
White blood cell (WBC) count elevated (leukocytosis)
|
41.7%
5/12 • Number of events 20 • up to 62 months
|
53.8%
7/13 • Number of events 15 • up to 62 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Ear and labyrinth disorders
Ringing in the ears (tinnitus)
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Eye disorders
Eye inflammation (scleral disorder)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Abdominal distention
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Abnormal sensation in the mouth (oral dysesthesia)
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 5 • up to 62 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 4 • up to 62 months
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Gastrointestinal disorders
Anemia
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Bleed (hemorrhage), gastrointestinal upper
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 3 • up to 62 months
|
|
Gastrointestinal disorders
Bloating
|
33.3%
4/12 • Number of events 7 • up to 62 months
|
30.8%
4/13 • Number of events 11 • up to 62 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 19 • up to 62 months
|
53.8%
7/13 • Number of events 23 • up to 62 months
|
|
Gastrointestinal disorders
Diarrhea
|
91.7%
11/12 • Number of events 36 • up to 62 months
|
46.2%
6/13 • Number of events 36 • up to 62 months
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
2/12 • Number of events 3 • up to 62 months
|
15.4%
2/13 • Number of events 5 • up to 62 months
|
|
Gastrointestinal disorders
Fluid in abdomen (ascites)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Gastrointestinal disorders
Gastroparesis
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Hemorrhage, anal
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Hemorrhage, hemorrhoidal
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 8 • up to 62 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 5 • up to 62 months
|
|
Gastrointestinal disorders
Indigestion (dyspepsia)
|
16.7%
2/12 • Number of events 5 • up to 62 months
|
23.1%
3/13 • Number of events 4 • up to 62 months
|
|
Gastrointestinal disorders
Inflammation of the lining of the stomach (gastritis)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Nausea
|
83.3%
10/12 • Number of events 38 • up to 62 months
|
69.2%
9/13 • Number of events 57 • up to 62 months
|
|
Gastrointestinal disorders
Oral inflammation (mucositis)
|
16.7%
2/12 • Number of events 4 • up to 62 months
|
23.1%
3/13 • Number of events 5 • up to 62 months
|
|
Gastrointestinal disorders
Other, excess in the stool (steatorrhea)
|
8.3%
1/12 • Number of events 3 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Other, stool discolored, clay color
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Pain
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Pain, abdominal
|
75.0%
9/12 • Number of events 22 • up to 62 months
|
76.9%
10/13 • Number of events 37 • up to 62 months
|
|
Gastrointestinal disorders
Pain, rectal
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Gastrointestinal disorders
Pain, stomach
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Gastrointestinal disorders
Swallowing difficulty (dysphagia)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Number of events 6 • up to 62 months
|
30.8%
4/13 • Number of events 19 • up to 62 months
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
23.1%
3/13 • Number of events 5 • up to 62 months
|
|
General disorders
Edema, localized
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
General disorders
Edema, peripheral
|
33.3%
4/12 • Number of events 8 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
General disorders
Fatigue
|
100.0%
12/12 • Number of events 63 • up to 62 months
|
76.9%
10/13 • Number of events 55 • up to 62 months
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
General disorders
Flu-like symptoms
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
15.4%
2/13 • Number of events 6 • up to 62 months
|
|
General disorders
General feeling of discomfort (malaise)
|
16.7%
2/12 • Number of events 2 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
General disorders
Infusion-related reaction
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
General disorders
Irritability
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
General disorders
Pain
|
25.0%
3/12 • Number of events 15 • up to 62 months
|
38.5%
5/13 • Number of events 9 • up to 62 months
|
|
General disorders
Pain, abdominal
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
General disorders
Pain, chest, non-cardiac
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Hepatobiliary disorders
Clot in portal vein (thrombosis)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 5 • up to 62 months
|
|
Hepatobiliary disorders
Platelet count decreased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Infections and infestations
Rash, papulopustular
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 3 • up to 62 months
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
6/12 • Number of events 22 • up to 62 months
|
38.5%
5/13 • Number of events 9 • up to 62 months
|
|
Investigations
Alkaline phosphatase decreased
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
Alkaline phosphatase increased
|
83.3%
10/12 • Number of events 43 • up to 62 months
|
69.2%
9/13 • Number of events 44 • up to 62 months
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
12/12 • Number of events 20 • up to 62 months
|
15.4%
2/13 • Number of events 4 • up to 62 months
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
Cardiac troponin increased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Investigations
Creatinine increased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Gamma-glutamyl transferase (GGT) increased
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
International normalized ratio (INR) increased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 4 • up to 62 months
|
|
Investigations
Leukocytosis
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Lipase increased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Lymphocyte count decreased
|
41.7%
5/12 • Number of events 13 • up to 62 months
|
61.5%
8/13 • Number of events 38 • up to 62 months
|
|
Investigations
Lymphocyte count increased
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
23.1%
3/13 • Number of events 4 • up to 62 months
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • Number of events 5 • up to 62 months
|
23.1%
3/13 • Number of events 8 • up to 62 months
|
|
Investigations
Other, Creatinine decreased
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
Other, Neutrophil count increase
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
Other, Protein total decrease
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
Other, WBC morphology
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Platelet count decreased
|
91.7%
11/12 • Number of events 61 • up to 62 months
|
69.2%
9/13 • Number of events 55 • up to 62 months
|
|
Investigations
Protein total decreased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Reduced red blood cells or hemoglobin (anemia)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Investigations
Weight gain
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Investigations
Weight loss
|
83.3%
10/12 • Number of events 39 • up to 62 months
|
30.8%
4/13 • Number of events 42 • up to 62 months
|
|
Investigations
White blood cell decreased
|
50.0%
6/12 • Number of events 13 • up to 62 months
|
38.5%
5/13 • Number of events 15 • up to 62 months
|
|
Metabolism and nutrition disorders
Decreased appetite (anorexia)
|
66.7%
8/12 • Number of events 29 • up to 62 months
|
30.8%
4/13 • Number of events 9 • up to 62 months
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
58.3%
7/12 • Number of events 27 • up to 62 months
|
76.9%
10/13 • Number of events 74 • up to 62 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
6/12 • Number of events 24 • up to 62 months
|
69.2%
9/13 • Number of events 64 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
3/12 • Number of events 13 • up to 62 months
|
46.2%
6/13 • Number of events 29 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
58.3%
7/12 • Number of events 15 • up to 62 months
|
38.5%
5/13 • Number of events 17 • up to 62 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
3/12 • Number of events 5 • up to 62 months
|
46.2%
6/13 • Number of events 14 • up to 62 months
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Metabolism and nutrition disorders
Other, Phosphate increased
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
1/12 • Number of events 5 • up to 62 months
|
15.4%
2/13 • Number of events 6 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
15.4%
2/13 • Number of events 3 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain (myalgia)
|
16.7%
2/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
16.7%
2/12 • Number of events 2 • up to 62 months
|
23.1%
3/13 • Number of events 17 • up to 62 months
|
|
Musculoskeletal and connective tissue disorders
Pain, flank
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Anxiety
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Bad taste in mouth (dysgeusia)
|
25.0%
3/12 • Number of events 8 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Nervous system disorders
Depression
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
23.1%
3/13 • Number of events 3 • up to 62 months
|
|
Nervous system disorders
Drowsiness, unusual (somnolence)
|
8.3%
1/12 • Number of events 11 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Excessive sleep (hypersomnia)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Feeling faint (presyncope)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Memory impairment
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Movements involuntary
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Nerve damage or injury (neuropathy)
|
58.3%
7/12 • Number of events 40 • up to 62 months
|
61.5%
8/13 • Number of events 29 • up to 62 months
|
|
Nervous system disorders
Nerve damage or injury (neuropathy), peripheral
|
0.00%
0/12 • up to 62 months
|
23.1%
3/13 • Number of events 6 • up to 62 months
|
|
Nervous system disorders
Nerve damage or injury (neuropathy), peripheral sensory
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Nerve tingling (paresthesia)
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
15.4%
2/13 • Number of events 3 • up to 62 months
|
|
Nervous system disorders
Nosebleed (epistaxis)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Other, muscle weakness
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Other, tremor
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Reduced albumin in the blood (hypoalbuminemia)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Nervous system disorders
Slow or slurred speech (dysarthria)
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Tiredness (fatigue)
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Psychiatric disorders
Amnesia
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Psychiatric disorders
Anxiety
|
25.0%
3/12 • Number of events 5 • up to 62 months
|
23.1%
3/13 • Number of events 15 • up to 62 months
|
|
Psychiatric disorders
Confusion
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • Number of events 5 • up to 62 months
|
23.1%
3/13 • Number of events 4 • up to 62 months
|
|
Psychiatric disorders
Difficulty sleeping (insomnia)
|
16.7%
2/12 • Number of events 2 • up to 62 months
|
15.4%
2/13 • Number of events 13 • up to 62 months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 3 • up to 62 months
|
|
Renal and urinary disorders
Excess protein in urine (proteinuria)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 7 • up to 62 months
|
|
Renal and urinary disorders
Urinary urgency
|
8.3%
1/12 • Number of events 2 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Renal and urinary disorders
Urine discoloration
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Respiratory, thoracic and mediastinal disorders
Edema, pulmonary
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • up to 62 months
|
30.8%
4/13 • Number of events 5 • up to 62 months
|
|
Respiratory, thoracic and mediastinal disorders
Labored breathing (dyspnea)
|
25.0%
3/12 • Number of events 3 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung collaspe (atelectasis)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 7 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Excessive sweating (hyperhidrosis)
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Hair loss, immune-realted (alopecia)
|
16.7%
2/12 • Number of events 10 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Itch (pruritus)
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 2 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, atypical junctional nevus
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, axilla boil
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, aypical melanocytic proliferation
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, bump on right upper extremity
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, deep mobile mass
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, medial right nodule on right upper extremity
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, melanoma in-situ
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Other, small nodule on right upper extremity
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 6 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Rash, maculo-papular
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/12 • up to 62 months
|
15.4%
2/13 • Number of events 2 • up to 62 months
|
|
Vascular disorders
Edema
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Vascular disorders
Hypertension
|
66.7%
8/12 • Number of events 32 • up to 62 months
|
61.5%
8/13 • Number of events 27 • up to 62 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • up to 62 months
|
7.7%
1/13 • Number of events 1 • up to 62 months
|
|
Vascular disorders
Lymphedema
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
|
Vascular disorders
Thromboembolic event
|
8.3%
1/12 • Number of events 1 • up to 62 months
|
0.00%
0/13 • up to 62 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place