Trial Outcomes & Findings for PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy (NCT NCT01333033)
NCT ID: NCT01333033
Last Updated: 2023-04-13
Results Overview
The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2023-04-13
Participant Flow
Participant milestones
| Measure |
FOLFOX Responder
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks.
|
FOLFOX Non-Responder
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.n Emission Tomography: Undergo PET/CT scan
|
CP Responder
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
|
CP Non-Responder
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
|
CP No Cross-over
Carboplatin/ Paclitaxel days 1,8,22,29
|
FOLFOX6 No Cross-over
modified FOLFOX6 days 1,15, 29
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
72
|
39
|
64
|
50
|
14
|
18
|
|
Overall Study
COMPLETED
|
72
|
39
|
64
|
50
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
14
|
18
|
Reasons for withdrawal
| Measure |
FOLFOX Responder
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks.
|
FOLFOX Non-Responder
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.n Emission Tomography: Undergo PET/CT scan
|
CP Responder
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
|
CP Non-Responder
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
|
CP No Cross-over
Carboplatin/ Paclitaxel days 1,8,22,29
|
FOLFOX6 No Cross-over
modified FOLFOX6 days 1,15, 29
|
|---|---|---|---|---|---|---|
|
Overall Study
Ineligible
|
0
|
0
|
0
|
0
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
4
|
2
|
|
Overall Study
PET inevaluable
|
0
|
0
|
0
|
0
|
2
|
4
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Progression
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
MD Decision
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
Baseline characteristics by cohort
| Measure |
Arm I (FOLFOX Regimen)
n=129 Participants
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.
Oxaliplatin: Given IV Leucovorin Calcium: Given IV Fluorouracil: Given IV Carboplatin: Given IV Paclitaxel: Given IV Positron Emission Tomography: Undergo PET/CT scan Computed Tomography: Undergo PET/CT scan Radiation Therapy: Undergo RT
|
Arm II (Carboplatin + Paclitaxel + Radiation)
n=128 Participants
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
Carboplatin: Given IV Paclitaxel: Given IV Radiation Therapy: Undergo RT
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
64 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
235 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
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=5 Participants
|
128 participants
n=7 Participants
|
257 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All eligible patients that registered to treatment and reported no PET/CT response to induction treatment were included in this endpoint.
The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Outcome measures
| Measure |
FOLFOX Non-Responder
n=39 Participants
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.\> \>\>\>
\>
\>\>\> Oxaliplatin: Given IV\>
\>\>\>
\>
\>\>\> Leucovorin Calcium: Given IV\>
\>\>\>
\>
\>\>\> Fluorouracil: Given IV\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Positron Emission Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Computed Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
CP Non-Responder
n=50 Participants
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
|---|---|---|
|
Complete Pathological Response (pCR) of PET/CT Non-responders
|
17.95 percentage of participants with a pCR
Interval 7.54 to 33.53
|
20 percentage of participants with a pCR
Interval 10.03 to 33.72
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants that were assessed for an induction response are included in this analysis.
A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as measured by maximum standardized uptake value (SUVmax).
Outcome measures
| Measure |
FOLFOX Non-Responder
n=111 Participants
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.\> \>\>\>
\>
\>\>\> Oxaliplatin: Given IV\>
\>\>\>
\>
\>\>\> Leucovorin Calcium: Given IV\>
\>\>\>
\>
\>\>\> Fluorouracil: Given IV\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Positron Emission Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Computed Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
CP Non-Responder
n=114 Participants
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
|---|---|---|
|
PET/CT Response Between Treatment Arms
|
64.86 percentage of patients with a response
Interval 55.23 to 73.69
|
56.14 percentage of patients with a response
Interval 46.54 to 65.42
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All eligible patients that were assessed as a PET responder by induction were included in this analysis.
A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as\> \>\> \>\> \>\> measured by maximum standardized uptake value (SUVmax). A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Outcome measures
| Measure |
FOLFOX Non-Responder
n=72 Participants
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.\> \>\>\>
\>
\>\>\> Oxaliplatin: Given IV\>
\>\>\>
\>
\>\>\> Leucovorin Calcium: Given IV\>
\>\>\>
\>
\>\>\> Fluorouracil: Given IV\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Positron Emission Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Computed Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
CP Non-Responder
n=64 Participants
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
|---|---|---|
|
pCR Compared Between Induction Treatment Arms Among PET/CT Responders
|
40.28 percentage of participants with a pCR
Interval 28.88 to 52.5
|
14.06 percentage of participants with a pCR
Interval 6.64 to 25.02
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients who completed induction therapy and were classified as a non-responder were included in this analysis.
A Complete Pathological Response (pCR) is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor. A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction.\> \>\>\> \> \>\>\> Among the patients who completed induction therapy and did not respond, the percentage of patients reporting a pCR in each arm were compared.
Outcome measures
| Measure |
FOLFOX Non-Responder
n=39 Participants
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.\> \>\>\>
\>
\>\>\> Oxaliplatin: Given IV\>
\>\>\>
\>
\>\>\> Leucovorin Calcium: Given IV\>
\>\>\>
\>
\>\>\> Fluorouracil: Given IV\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Positron Emission Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Computed Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
CP Non-Responder
n=50 Participants
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
|---|---|---|
|
pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious
|
17.95 percentage of participants with a pCR
Interval 7.54 to 33.53
|
20 percentage of participants with a pCR
Interval 10.03 to 33.72
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients that began induction therapy and did not report a response were included in this analysis.
A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction. Among the patients who completed induction therapy and did not respond, the progression free survival in each arm were compared. PFS will be measured from study entry until documented progression or death from any cause. PFS will be estimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
FOLFOX Non-Responder
n=39 Participants
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.\> \>\>\>
\>
\>\>\> Oxaliplatin: Given IV\>
\>\>\>
\>
\>\>\> Leucovorin Calcium: Given IV\>
\>\>\>
\>
\>\>\> Fluorouracil: Given IV\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Positron Emission Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Computed Tomography: Undergo PET/CT scan\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
CP Non-Responder
n=50 Participants
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT\>
\>\>\>
\>
\>\>\> Carboplatin: Given IV\>
\>\>\>
\>
\>\>\> Paclitaxel: Given IV\>
\>\>\>
\>
\>\>\> Radiation Therapy: Undergo RT
|
|---|---|---|
|
Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group
|
NA months
Interval 27.8 to
Too few events have been recorded to estimate the median and upper confidence interval.
|
33.4 months
Interval 17.2 to
Too few events have been recorded to estimate the upper confidence interval.
|
Adverse Events
FOLFOX Responder
Serious events: 3 serious events
Other events: 72 other events
Deaths: 3 deaths
FOLFOX Non-Responder
Serious events: 1 serious events
Other events: 38 other events
Deaths: 1 deaths
CP Responder
Serious events: 2 serious events
Other events: 63 other events
Deaths: 2 deaths
CP Non-Responder
Serious events: 4 serious events
Other events: 46 other events
Deaths: 4 deaths
CP No Cross-over
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
FOLFOX No Cross-over
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFOX Responder
n=72 participants at risk
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks.
|
FOLFOX Non-Responder
n=39 participants at risk
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.n Emission Tomography: Undergo PET/CT scan
|
CP Responder
n=64 participants at risk
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
|
CP Non-Responder
n=49 participants at risk
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
|
CP No Cross-over
n=9 participants at risk
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses.
|
FOLFOX No Cross-over
n=5 participants at risk
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Esophageal perforation
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
Other adverse events
| Measure |
FOLFOX Responder
n=72 participants at risk
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks.
|
FOLFOX Non-Responder
n=39 participants at risk
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.n Emission Tomography: Undergo PET/CT scan
|
CP Responder
n=64 participants at risk
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
|
CP Non-Responder
n=49 participants at risk
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks.
|
CP No Cross-over
n=9 participants at risk
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses.
|
FOLFOX No Cross-over
n=5 participants at risk
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Esophageal fistula
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
6/72 • Number of events 19 • 5 years
|
17.9%
7/39 • Number of events 11 • 5 years
|
7.8%
5/64 • Number of events 9 • 5 years
|
20.4%
10/49 • Number of events 15 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
3.1%
2/64 • Number of events 6 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/72 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.8%
2/72 • Number of events 4 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
4.2%
3/72 • Number of events 13 • 5 years
|
2.6%
1/39 • Number of events 5 • 5 years
|
4.7%
3/64 • Number of events 4 • 5 years
|
4.1%
2/49 • Number of events 3 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 2 • 5 years
|
8.2%
4/49 • Number of events 5 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Atrioventricular block complete
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Cardiac disorders
Heart failure
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/72 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Pericarditis
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 4 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
40.0%
2/5 • Number of events 2 • 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
1/72 • Number of events 1 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 3 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 3 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Eye disorders
Blurred vision
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Eye disorders
Cataract
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 3 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/72 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
8.3%
6/72 • Number of events 15 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
4.7%
3/64 • Number of events 5 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
36/72 • Number of events 87 • 5 years
|
41.0%
16/39 • Number of events 24 • 5 years
|
35.9%
23/64 • Number of events 39 • 5 years
|
40.8%
20/49 • Number of events 42 • 5 years
|
11.1%
1/9 • Number of events 2 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/72 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
13.9%
10/72 • Number of events 36 • 5 years
|
28.2%
11/39 • Number of events 28 • 5 years
|
10.9%
7/64 • Number of events 10 • 5 years
|
16.3%
8/49 • Number of events 19 • 5 years
|
11.1%
1/9 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Esophageal obstruction
|
1.4%
1/72 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
1.6%
1/64 • Number of events 3 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Esophageal pain
|
1.4%
1/72 • Number of events 1 • 5 years
|
7.7%
3/39 • Number of events 4 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
8.3%
6/72 • Number of events 11 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
3.1%
2/64 • Number of events 2 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.8%
2/72 • Number of events 6 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 2 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Gastroparesis
|
1.4%
1/72 • Number of events 3 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Jejunal fistula
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Malabsorption
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
4.1%
2/49 • Number of events 6 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
5.6%
4/72 • Number of events 4 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
77.8%
56/72 • Number of events 192 • 5 years
|
79.5%
31/39 • Number of events 88 • 5 years
|
65.6%
42/64 • Number of events 89 • 5 years
|
77.6%
38/49 • Number of events 120 • 5 years
|
66.7%
6/9 • Number of events 9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
11.1%
1/9 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
45.8%
33/72 • Number of events 66 • 5 years
|
46.2%
18/39 • Number of events 37 • 5 years
|
28.1%
18/64 • Number of events 29 • 5 years
|
40.8%
20/49 • Number of events 46 • 5 years
|
33.3%
3/9 • Number of events 5 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
General disorders
Chills
|
1.4%
1/72 • Number of events 1 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
General disorders
Edema limbs
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 4 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
General disorders
Fatigue
|
20.8%
15/72 • Number of events 39 • 5 years
|
23.1%
9/39 • Number of events 22 • 5 years
|
6.2%
4/64 • Number of events 4 • 5 years
|
12.2%
6/49 • Number of events 12 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
General disorders
Fever
|
15.3%
11/72 • Number of events 16 • 5 years
|
10.3%
4/39 • Number of events 5 • 5 years
|
15.6%
10/64 • Number of events 15 • 5 years
|
16.3%
8/49 • Number of events 9 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
General disorders
Flu like symptoms
|
5.6%
4/72 • Number of events 14 • 5 years
|
10.3%
4/39 • Number of events 4 • 5 years
|
4.7%
3/64 • Number of events 5 • 5 years
|
4.1%
2/49 • Number of events 3 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
General disorders
Pain
|
4.2%
3/72 • Number of events 4 • 5 years
|
5.1%
2/39 • Number of events 4 • 5 years
|
4.7%
3/64 • Number of events 4 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Device related infection
|
1.4%
1/72 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.4%
1/72 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Lung infection
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
4.1%
2/49 • Number of events 3 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
40.0%
2/5 • Number of events 2 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
3/72 • Number of events 6 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
4/72 • Number of events 9 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Blood bilirubin increased
|
2.8%
2/72 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
1.4%
1/72 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
INR increased
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
36.1%
26/72 • Number of events 66 • 5 years
|
38.5%
15/39 • Number of events 23 • 5 years
|
42.2%
27/64 • Number of events 37 • 5 years
|
38.8%
19/49 • Number of events 53 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
24/72 • Number of events 46 • 5 years
|
46.2%
18/39 • Number of events 24 • 5 years
|
46.9%
30/64 • Number of events 50 • 5 years
|
30.6%
15/49 • Number of events 37 • 5 years
|
44.4%
4/9 • Number of events 4 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
Platelet count decreased
|
61.1%
44/72 • Number of events 145 • 5 years
|
64.1%
25/39 • Number of events 52 • 5 years
|
68.8%
44/64 • Number of events 69 • 5 years
|
51.0%
25/49 • Number of events 71 • 5 years
|
22.2%
2/9 • Number of events 2 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Investigations
Weight loss
|
5.6%
4/72 • Number of events 9 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
0.00%
0/64 • 5 years
|
6.1%
3/49 • Number of events 5 • 5 years
|
11.1%
1/9 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
|
Investigations
White blood cell decreased
|
2.8%
2/72 • Number of events 4 • 5 years
|
20.5%
8/39 • Number of events 8 • 5 years
|
21.9%
14/64 • Number of events 16 • 5 years
|
2.0%
1/49 • Number of events 5 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
9.7%
7/72 • Number of events 15 • 5 years
|
15.4%
6/39 • Number of events 7 • 5 years
|
3.1%
2/64 • Number of events 2 • 5 years
|
8.2%
4/49 • Number of events 5 • 5 years
|
11.1%
1/9 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
3/72 • Number of events 4 • 5 years
|
12.8%
5/39 • Number of events 7 • 5 years
|
4.7%
3/64 • Number of events 3 • 5 years
|
10.2%
5/49 • Number of events 5 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
4/72 • Number of events 10 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
6.2%
4/64 • Number of events 7 • 5 years
|
4.1%
2/49 • Number of events 11 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.2%
3/72 • Number of events 5 • 5 years
|
5.1%
2/39 • Number of events 5 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.8%
2/72 • Number of events 2 • 5 years
|
7.7%
3/39 • Number of events 6 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.8%
2/72 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
3/72 • Number of events 3 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
10.2%
5/49 • Number of events 7 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/72 • 5 years
|
10.3%
4/39 • Number of events 4 • 5 years
|
4.7%
3/64 • Number of events 4 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
6/72 • Number of events 16 • 5 years
|
7.7%
3/39 • Number of events 5 • 5 years
|
20.3%
13/64 • Number of events 25 • 5 years
|
10.2%
5/49 • Number of events 14 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.2%
3/72 • Number of events 4 • 5 years
|
0.00%
0/39 • 5 years
|
3.1%
2/64 • Number of events 2 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
6/72 • Number of events 18 • 5 years
|
10.3%
4/39 • Number of events 7 • 5 years
|
17.2%
11/64 • Number of events 15 • 5 years
|
8.2%
4/49 • Number of events 6 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 3 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Dizziness
|
4.2%
3/72 • Number of events 5 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
4.1%
2/49 • Number of events 5 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
2.8%
2/72 • Number of events 6 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Headache
|
16.7%
12/72 • Number of events 27 • 5 years
|
15.4%
6/39 • Number of events 7 • 5 years
|
23.4%
15/64 • Number of events 26 • 5 years
|
6.1%
3/49 • Number of events 8 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Nervous system disorders
Paresthesia
|
44.4%
32/72 • Number of events 120 • 5 years
|
41.0%
16/39 • Number of events 35 • 5 years
|
17.2%
11/64 • Number of events 30 • 5 years
|
24.5%
12/49 • Number of events 34 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
25.0%
18/72 • Number of events 37 • 5 years
|
12.8%
5/39 • Number of events 11 • 5 years
|
21.9%
14/64 • Number of events 21 • 5 years
|
8.2%
4/49 • Number of events 12 • 5 years
|
33.3%
3/9 • Number of events 7 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.8%
2/72 • Number of events 6 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Presyncope
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Nervous system disorders
Syncope
|
2.8%
2/72 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/72 • Number of events 2 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
11.1%
1/9 • Number of events 1 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 3 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/72 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
2/72 • Number of events 5 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
12/72 • Number of events 36 • 5 years
|
25.6%
10/39 • Number of events 15 • 5 years
|
26.6%
17/64 • Number of events 30 • 5 years
|
42.9%
21/49 • Number of events 67 • 5 years
|
22.2%
2/9 • Number of events 2 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
3/72 • Number of events 7 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.4%
1/72 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
4.7%
3/64 • Number of events 3 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
9.7%
7/72 • Number of events 26 • 5 years
|
10.3%
4/39 • Number of events 8 • 5 years
|
7.8%
5/64 • Number of events 8 • 5 years
|
10.2%
5/49 • Number of events 11 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
1.6%
1/64 • Number of events 2 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
4.1%
2/49 • Number of events 3 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/72 • Number of events 1 • 5 years
|
5.1%
2/39 • Number of events 6 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
11.1%
1/9 • Number of events 2 • 5 years
|
0.00%
0/5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
1/72 • Number of events 8 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/72 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.4%
1/72 • Number of events 2 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
3.1%
2/64 • Number of events 2 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Vascular disorders
Flushing
|
0.00%
0/72 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension
|
1.4%
1/72 • Number of events 3 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
3.1%
2/64 • Number of events 4 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
1.4%
1/72 • Number of events 1 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
3.1%
2/64 • Number of events 2 • 5 years
|
4.1%
2/49 • Number of events 2 • 5 years
|
0.00%
0/9 • 5 years
|
20.0%
1/5 • Number of events 1 • 5 years
|
|
Vascular disorders
Phlebitis
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/64 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
5.6%
4/72 • Number of events 5 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
1.6%
1/64 • Number of events 1 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/72 • 5 years
|
2.6%
1/39 • Number of events 4 • 5 years
|
1.6%
1/64 • Number of events 3 • 5 years
|
0.00%
0/49 • 5 years
|
0.00%
0/9 • 5 years
|
0.00%
0/5 • 5 years
|
Additional Information
Karyn Goodman, M.D.
Alliance for Clinical Trials in Oncology
Phone: (212) 639-3983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60