Trial Outcomes & Findings for Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas (NCT NCT01595321)
NCT ID: NCT01595321
Last Updated: 2024-08-14
Results Overview
The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-08-14
Participant Flow
Participant milestones
| Measure |
Cohort 1: SBRT and FOLFIRINOX
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
Cyclophosphamide: Cyclophosphamide (CY) 200 mg/m\^2 was administered one day prior to GVAX (day 0). GVAX Pancreas Vaccine (GVAX) will be administered one day after CY (day 1). One Cycle of Cy/GVAX was given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
12
|
|
Overall Study
COMPLETED
|
2
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
Reasons for withdrawal
| Measure |
Cohort 1: SBRT and FOLFIRINOX
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
Cyclophosphamide: Cyclophosphamide (CY) 200 mg/m\^2 was administered one day prior to GVAX (day 0). GVAX Pancreas Vaccine (GVAX) will be administered one day after CY (day 1). One Cycle of Cy/GVAX was given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle): Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
4
|
Baseline Characteristics
Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 Participants
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
55 years
n=7 Participants
|
58 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Classification
ECOG 0
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Classification
ECOG 1
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: One patient in cohort 2 was not evaluable because they did not complete 2 cycles of FOLFIRINOX.
The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort.
Outcome measures
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 Participants
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Dose Limiting Toxicities
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Dose Limiting Toxicities
Neutropenia
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Dose Limiting Toxicities
Thrombocytopenia
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 116 monthsPopulation: Only Cohort 3 received Cy and GVAX and could be evaluated for this outcome.
Number of participants with grade 3 or above adverse event attributed to Cy or the GVAX pancreas vaccine. Each adverse event (as defined by NCI CTCAE v4.0) was counted only once for a given subject.
Outcome measures
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=12 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Grade 3 or Higher Cy/GVAX-related Adverse Events
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 96 monthsOS was measured as the amount of time from date of surgery until death or end of follow-up. OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 Participants
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Overall Survival (OS)
|
22.2 months
Interval 6.74 to
upper limit goes to infinity
|
27.5 months
Interval 16.3 to
upper limit goes to infinity
|
61.3 months
Interval 11.1 to
upper limit goes to infinity
|
SECONDARY outcome
Timeframe: 96 monthsDFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 Participants
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Disease-free Survival (DFS)
|
10.5 months
Interval 3.45 to
upper limit goes to infinity
|
14.5 months
Interval 10.1 to
upper limit goes to infinity
|
24.1 months
Interval 11.1 to
upper limit goes to infinity
|
SECONDARY outcome
Timeframe: 96 monthsDMFS was measured as the amount of time from date of surgery until metastatic disease progression or death. Metastatic disease progression is the appearance of one or more new lesions outside the primary tumor area (pancreas). Disease status was monitored by radiologic scans done approximately every 12 weeks. DMFS was censored on the date of last radiographic scans for subjects without documentation of metastatic disease progression or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 Participants
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Distant Metastases Free Survival (DMFS)
|
10.5 months
Interval 3.45 to
upper limit goes to infinity
|
19.0 months
Interval 10.15 to
upper limit goes to infinity
|
42.0 months
Interval 11.1 to
upper limit goes to infinity
|
SECONDARY outcome
Timeframe: 96 monthsFFLP was measured as the time from date of surgery until disease recurrence in the pancreas or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. FFLP was censored on the date of last radiographic scans for subjects without documentation of local disease recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 Participants
Stereotactic Body Radiation Therapy (SBRT, 33 Gy cumulative dose) was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of FOLFIRINOX were given starting 7-28 days after completion of SBRT. Full dose FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions of FOLFIRINOX were permitted.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting 6-10 weeks after pancreas surgical resection (Whipple procedure).
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 Participants
Cyclophosphamide (Cy) 200 mg/m\^2 was administered on Day 0 of each vaccine cycle. GVAX Pancreas Vaccine (GVAX) was administered one day after Cy (Day 1 of each cycle). The first Cycle of Cy/GVAX was given 6-10 weeks after pancreas surgical resection (prior to SBRT and FOLFIRINOX). Four additional doses were given after FOLFIRINOX completion for a total of 5 priming doses. Additional Cy/GVAX boosts were given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation Therapy (SBRT), 33 Gy cumulative dose, was administered to the surgical bed over 5 days, starting about 2 weeks after the first dose of Cy/GVAX.
Six 28-day cycles of modified FOLFIRINOX were given, starting 7-28 days after completion of SBRT. Modified FOLFIRINOX consists of the following drugs, given IV on Days 1 and 15 of each cycle: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). Dose reductions were permitted.
|
|---|---|---|---|
|
Freedom From Local Progression (FFLP)
|
17.3 months
Interval 6.74 to
upper limit goes to infinity
|
20.5 months
Interval 10.8 to
upper limit goes to infinity
|
34.0 months
Interval 11.1 to
upper limit goes to infinity
|
Adverse Events
Cohort 1: SBRT and FOLFIRINOX
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 2: SBRT and Modified FOLFIRINOX
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 participants at risk
Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days within 6-10 weeks of surgery (Whipple).
FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT. Each cycle is 28 days long.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 participants at risk
Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days within 6-10 weeks of surgery (Whipple).
FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT. Each cycle is 28 days long.
The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 participants at risk
Cyclophosphamide: Cyclophosphamide (CY) 200 mg/m\^2 will be administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
GVAX Pancreas Vaccine: GVAX will be administered one day after CY (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX.
FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT and at least 28 days after the first vaccine. Each cycle is 28 days long.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Infections and infestations
Catheter realted infection
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • Number of events 3 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Small intestinal obstruction, partial
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
Other adverse events
| Measure |
Cohort 1: SBRT and FOLFIRINOX
n=3 participants at risk
Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days within 6-10 weeks of surgery (Whipple).
FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT. Each cycle is 28 days long.
|
Cohort 2: SBRT and Modified FOLFIRINOX
n=4 participants at risk
Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days within 6-10 weeks of surgery (Whipple).
FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT. Each cycle is 28 days long.
The difference between Cohort 1 and 2 is that the Fluorouracil bolus was dropped in Cohort 2.
|
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX
n=12 participants at risk
Cyclophosphamide: Cyclophosphamide (CY) 200 mg/m\^2 will be administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
GVAX Pancreas Vaccine: GVAX will be administered one day after CY (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation (SBRT, 6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX.
FOLFIRINOX: FOLFIRINOX consist of the following: Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (2,400 mg/m\^2 continuous infusion over 46-48 hours). FOLFIRINOX will be administered over 6 cycles (Days 1 and 15 of each cycle) starting 7-28 days following completion of SBRT and at least 28 days after the first vaccine. Each cycle is 28 days long.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 3 • 116 months
|
75.0%
3/4 • Number of events 5 • 116 months
|
66.7%
8/12 • Number of events 9 • 116 months
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Number of events 3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
41.7%
5/12 • Number of events 6 • 116 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 3 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Vascular disorders
Annuloaortic ectasia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
50.0%
6/12 • Number of events 8 • 116 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 5 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis (gout)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Ascities
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Blood and lymphatic system disorders
Blood and lymphativ system disorders, lymphadenopathy
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
100.0%
3/3 • Number of events 6 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
0.00%
0/12 • 116 months
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Injury, poisoning and procedural complications
Bruising (vaccine site)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
General disorders
Chills
|
100.0%
3/3 • Number of events 3 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
41.7%
5/12 • Number of events 8 • 116 months
|
|
General disorders
Cold intolerance
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Nervous system disorders
Concentration impairment
|
33.3%
1/3 • Number of events 1 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 116 months
|
50.0%
2/4 • Number of events 3 • 116 months
|
25.0%
3/12 • Number of events 5 • 116 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Vascular disorders
Coronary arterial calcification
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breath sounds
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
33.3%
4/12 • Number of events 4 • 116 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 15 • 116 months
|
75.0%
3/4 • Number of events 7 • 116 months
|
83.3%
10/12 • Number of events 24 • 116 months
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
58.3%
7/12 • Number of events 7 • 116 months
|
|
Skin and subcutaneous tissue disorders
Dry Lips
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
66.7%
2/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
25.0%
3/12 • Number of events 5 • 116 months
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • 116 months
|
75.0%
3/4 • Number of events 3 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
50.0%
6/12 • Number of events 6 • 116 months
|
|
General disorders
Edema face
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
50.0%
6/12 • Number of events 11 • 116 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
66.7%
2/3 • Number of events 3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
41.7%
5/12 • Number of events 5 • 116 months
|
|
Skin and subcutaneous tissue disorders
Erythema mutliforme
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
16.7%
2/12 • Number of events 3 • 116 months
|
|
Eye disorders
Eye disorder
|
0.00%
0/3 • 116 months
|
50.0%
2/4 • Number of events 3 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 4 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • 116 months
|
75.0%
3/4 • Number of events 6 • 116 months
|
91.7%
11/12 • Number of events 24 • 116 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
33.3%
1/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 2 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
50.0%
6/12 • Number of events 11 • 116 months
|
|
Gastrointestinal disorders
Flatulence
|
66.7%
2/3 • Number of events 2 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
25.0%
3/12 • Number of events 5 • 116 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
33.3%
4/12 • Number of events 7 • 116 months
|
|
Infections and infestations
Gall bladder infection
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Hepatobiliary disorders
Gall bladder obstruction
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders- others, specify (dark stools)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 116 months
|
75.0%
3/4 • Number of events 6 • 116 months
|
33.3%
4/12 • Number of events 5 • 116 months
|
|
Ear and labyrinth disorders
Hearing imaired
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Infections and infestations
Hepatic infection
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Vascular disorders
Hematoma, liver
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Vascular disorders
Hematoma, Mediport
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 3 • 116 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
33.3%
4/12 • Number of events 4 • 116 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
50.0%
6/12 • Number of events 17 • 116 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
0.00%
0/12 • 116 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 5 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
41.7%
5/12 • Number of events 5 • 116 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Number of events 3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 3 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • 116 months
|
75.0%
3/4 • Number of events 5 • 116 months
|
41.7%
5/12 • Number of events 6 • 116 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 2 • 116 months
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Infections and infestations
Lip infection
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 5 • 116 months
|
25.0%
1/4 • Number of events 4 • 116 months
|
50.0%
6/12 • Number of events 21 • 116 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Social circumstances
Menopause
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Infections and infestations
Mucoasal infection
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Gastrointestinal disorders
Mucositis (oral ulcers)
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 5 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 5 • 116 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • 116 months
|
75.0%
3/4 • Number of events 6 • 116 months
|
66.7%
8/12 • Number of events 15 • 116 months
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 4 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 6 • 116 months
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 3 • 116 months
|
50.0%
2/4 • Number of events 4 • 116 months
|
58.3%
7/12 • Number of events 9 • 116 months
|
|
Skin and subcutaneous tissue disorders
Pallor
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Investigations
Pancreatic enzymes decreased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • 116 months
|
100.0%
4/4 • Number of events 5 • 116 months
|
83.3%
10/12 • Number of events 11 • 116 months
|
|
Endocrine disorders
Photophobia
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 5 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
33.3%
4/12 • Number of events 13 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Hepatobiliary disorders
Pneumobilia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 3 • 116 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 2 • 116 months
|
41.7%
5/12 • Number of events 10 • 116 months
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 4 • 116 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cysts
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder - other, tracheal deviation
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 2 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue disorder
|
33.3%
1/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
50.0%
6/12 • Number of events 6 • 116 months
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Skin and subcutaneous tissue disorders
skin discoloration
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Skin and subcutaneous tissue disorders
Skin tears
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Gastrointestinal disorders
Small intestinal obstruction, partial
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 5 • 116 months
|
0.00%
0/12 • 116 months
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Number of events 3 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Number of events 1 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Immune system disorders
Thymic hyperplasia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 2 • 116 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Musculoskeletal and connective tissue disorders
Vertebral compression
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
16.7%
2/12 • Number of events 2 • 116 months
|
|
Cardiac disorders
Ventricular gallop
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 3 • 116 months
|
50.0%
2/4 • Number of events 2 • 116 months
|
33.3%
4/12 • Number of events 6 • 116 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
0.00%
0/12 • 116 months
|
|
Investigations
Weight loss
|
66.7%
2/3 • Number of events 4 • 116 months
|
0.00%
0/4 • 116 months
|
50.0%
6/12 • Number of events 11 • 116 months
|
|
Investigations
White blood
|
66.7%
2/3 • Number of events 2 • 116 months
|
0.00%
0/4 • 116 months
|
0.00%
0/12 • 116 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
33.3%
1/3 • Number of events 1 • 116 months
|
25.0%
1/4 • Number of events 1 • 116 months
|
25.0%
3/12 • Number of events 3 • 116 months
|
|
Skin and subcutaneous tissue disorders
Erythema (Vaccine site)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
100.0%
12/12 • Number of events 63 • 116 months
|
|
Skin and subcutaneous tissue disorders
Induration (Vaccine Site)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
100.0%
12/12 • Number of events 65 • 116 months
|
|
Skin and subcutaneous tissue disorders
Prutitus (Vaccine site)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
91.7%
11/12 • Number of events 54 • 116 months
|
|
Skin and subcutaneous tissue disorders
Skin discoloration (Vaccine Site)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
25.0%
3/12 • Number of events 6 • 116 months
|
|
Skin and subcutaneous tissue disorders
Tenderness (Vaccine Site)
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
75.0%
9/12 • Number of events 26 • 116 months
|
|
Skin and subcutaneous tissue disorders
Vaccine Site Flares
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
41.7%
5/12 • Number of events 11 • 116 months
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
|
Hepatobiliary disorders
Steatosis
|
0.00%
0/3 • 116 months
|
0.00%
0/4 • 116 months
|
8.3%
1/12 • Number of events 1 • 116 months
|
Additional Information
Daniel Laheru, MD
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place