Trial Outcomes & Findings for Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers (NCT NCT03515941)
NCT ID: NCT03515941
Last Updated: 2020-10-12
Results Overview
The number of patients who complete the recommended therapy will be counted for each arm.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
6 participants
Primary outcome timeframe
From date of assigned therapy up to 17 weeks
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
Arm 1: Adjuvant Chemotherapy
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Adjuvant Chemotherapy
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers
Baseline characteristics by cohort
| Measure |
Total
n=6 Participants
Total of all reporting groups
|
Arm 1: Adjuvant Chemotherapy
n=4 Participants
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
n=2 Participants
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
ECOG performance status
ECOG score 0
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
ECOG performance status
ECOG score 1
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From date of assigned therapy up to 17 weeksThe number of patients who complete the recommended therapy will be counted for each arm.
Outcome measures
| Measure |
Arm 1: Adjuvant Chemotherapy
n=4 Participants
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
n=2 Participants
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|
|
Number of Participants Who Complete the Recommended Therapy From Each Arm
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closurePopulation: All patients who are enrolled on the study and begin any of their intended post-operative adjuvant therapy will be counted as evaluable for the study. This inclusion will be regardless of how much of the postoperative treatment they ultimately receive.
Disease recurrence will be defined as radiographic tumor evidence detected by surveillance imaging. Confirmation of recurrence by biopsy will be at the discretion of the treating physician. This study closed early on June 18, 2020. It was earlier than one planned because of the lack of accrual.
Outcome measures
| Measure |
Arm 1: Adjuvant Chemotherapy
n=4 Participants
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
n=2 Participants
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|
|
Median Time to Recurrence
|
NA months
Interval 5.96 to
The median recurrence time was NA therefore the upper 95% confidence interval is NA.
|
NA months
There was no recurrence occurred during the time period we observed. Therefore, the recurrence has not been reached to the median.
|
Adverse Events
Arm 1: Adjuvant Chemotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: Adjuvant Chemoradiation
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Adjuvant Chemotherapy
n=4 participants at risk
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
n=2 participants at risk
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
Other adverse events
| Measure |
Arm 1: Adjuvant Chemotherapy
n=4 participants at risk
Three cycles of chemo with CAPEOX (Oxaliplatin:130 mg/m2 by IV and Capecitabine: 625 or 1000 mg/m2 by PO (BID) on 21 day-cycle or FOLFOX (Oxaliplatin:85 mg/m2 by IV, Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 2400 mg/m2 by IV) on 14 day-cycle
Oxaliplatin: 130 mg/m2 by IV (Arm 1)
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
|
Arm 2: Adjuvant Chemoradiation
n=2 participants at risk
Three cycles of chemo with Capecitabine: 750 mg/m2 by PO BID on days 1-14 of a 28 day-cycle or 5-fluorouracil (Leucovorin:400 mg/m2 by IV,5-fluorouracil: 400 mg/m2 and 1200 mg/m2 by IV) on days 1 and 15 of a 28 day cycle After 1st chemo cycle above, chemoradiation for 5 weeks with 45 Gy in 1.8 Gy/fraction, 5 days a week, to the entire gastric bed (including anastomosis) and draining lymph nodes, and a single agent fluoropyrimidine, either capecitabine or 5-fluorouracil After 5 weeks chemoradiation, 2 cycles of chemo as described above.
Capecitabine: 625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
Leucovorin: 400 mg/m2 by IV (Arm 1 \& Arm 2)
5-fluorouracil: 400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
radiation: 45 Gy in 1.8 Gy/fraction
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
0.00%
0/2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
General disorders
Pain
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Injury, poisoning and procedural complications
Bruising
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
0.00%
0/2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
0.00%
0/2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
Weight loss
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
0.00%
0/2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
100.0%
2/2 • Number of events 2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
0.00%
0/2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
0.00%
0/2 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
50.0%
1/2 • Number of events 1 • From the end of completion of assigned therapy, subjects undergo follow-up every 3 months for a total of 36 months(planned) after the date of surgery or until the study closure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place