Trial Outcomes & Findings for Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer (NCT NCT00711412)
NCT ID: NCT00711412
Last Updated: 2018-07-18
Results Overview
Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
At time of surgery
Results posted on
2018-07-18
Participant Flow
The study opened for accrual on May 31, 2006 with an accrual goal of up to 43 patients. The study was designed to enroll 13 patients initially and do an interim efficacy assessment. Accrual was suspended on July 17, 2008 for this analysis and reopened on August 12, 2008. The study was closed permanently on february 24, 2009.
Participant milestones
| Measure |
Induction and Combination Treatment
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Induction Treatment
STARTED
|
44
|
|
Induction Treatment
Registered to Study
|
44
|
|
Induction Treatment
Started Induction Treatment
|
43
|
|
Induction Treatment
COMPLETED
|
40
|
|
Induction Treatment
NOT COMPLETED
|
4
|
|
Evaluated for Combination Treatment
STARTED
|
40
|
|
Evaluated for Combination Treatment
COMPLETED
|
34
|
|
Evaluated for Combination Treatment
NOT COMPLETED
|
6
|
|
Combination Treatment
STARTED
|
34
|
|
Combination Treatment
COMPLETED
|
33
|
|
Combination Treatment
NOT COMPLETED
|
1
|
|
Evaluation for Response and Surgery
STARTED
|
34
|
|
Evaluation for Response and Surgery
COMPLETED
|
28
|
|
Evaluation for Response and Surgery
NOT COMPLETED
|
6
|
|
Survival Follow up Until Death
STARTED
|
38
|
|
Survival Follow up Until Death
COMPLETED
|
26
|
|
Survival Follow up Until Death
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Induction and Combination Treatment
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Induction Treatment
Death
|
2
|
|
Induction Treatment
Adverse Event
|
1
|
|
Induction Treatment
Other
|
1
|
|
Evaluated for Combination Treatment
Adverse Event
|
2
|
|
Evaluated for Combination Treatment
Death
|
1
|
|
Evaluated for Combination Treatment
Withdrawal by Subject
|
1
|
|
Evaluated for Combination Treatment
Progressive disease
|
2
|
|
Combination Treatment
Progressive Disease
|
1
|
|
Evaluation for Response and Surgery
Progressive Disease
|
2
|
|
Evaluation for Response and Surgery
Too high risk for surgery
|
2
|
|
Evaluation for Response and Surgery
Withdrawal by Subject
|
1
|
|
Evaluation for Response and Surgery
Death
|
1
|
|
Survival Follow up Until Death
Other
|
12
|
Baseline Characteristics
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Induction and Combination Treatment
n=44 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At time of surgeryPopulation: Patients analyzed were patients that reached and completed surgery.
Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer
Outcome measures
| Measure |
Induction, Combination and Surgery
n=28 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Determine Pathologic Complete Response
|
9 Participants
|
SECONDARY outcome
Timeframe: four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgeryPopulation: 1 patient was registered to the study but was not treated on study and was therefore not evaluable.
Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) . Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD
Outcome measures
| Measure |
Induction, Combination and Surgery
n=43 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Clinical Response Rate
|
28 Participants
|
SECONDARY outcome
Timeframe: From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.Population: 1 patient was registered but not treated on study and therefore was not evaluable.
Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.
Outcome measures
| Measure |
Induction, Combination and Surgery
n=43 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Recurrence Rate
|
23 Participants
|
SECONDARY outcome
Timeframe: From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.Population: Data collected was not analyzed before the study was terminated. Count of participants indicates the number of patients with progressive disease or death at the time the study closed permanently.
Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.
Outcome measures
| Measure |
Induction, Combination and Surgery
n=43 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Time to Progression
|
28 Participants
|
SECONDARY outcome
Timeframe: At time of surgeryPopulation: No data collected for this outcome measure. There is no data to report on.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.Population: Toxicity data was collected and analysed for the first 40 patients.
Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0) In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Only incidents of AEs determined to be related to chemotherapy are recorded here.
Outcome measures
| Measure |
Induction, Combination and Surgery
n=40 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Toxicity Profile
Thrombocytopenia
|
20 participants
|
|
Toxicity Profile
Anemia
|
17 participants
|
|
Toxicity Profile
lymphopenia
|
16 participants
|
|
Toxicity Profile
Leukopenia
|
15 participants
|
|
Toxicity Profile
Neutropenia
|
8 participants
|
|
Toxicity Profile
Thrombosis
|
5 participants
|
|
Toxicity Profile
Nausea
|
18 participants
|
|
Toxicity Profile
Diarrhea
|
15 participants
|
|
Toxicity Profile
Dysphagia
|
15 participants
|
|
Toxicity Profile
Vomiting
|
8 participants
|
|
Toxicity Profile
Constipatation
|
7 participants
|
|
Toxicity Profile
Abdominal pain
|
6 participants
|
|
Toxicity Profile
Stomatitis
|
6 participants
|
|
Toxicity Profile
Esophgitis
|
4 participants
|
SECONDARY outcome
Timeframe: At time of sugeryPopulation: No data was collected for this outcome measure. There is no data to report on.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: After cycles 2, and 4 (pre-surgery) 30 days after surgery and then every 3 months until first documentation of progressive disease, death and up to a maximum of 24 months.Population: The only data collected for this outcome measure was progression free survival rate at 3 months, 6 months, and 12 months.
Outcome measures
| Measure |
Induction, Combination and Surgery
n=43 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Determine Progressive Free Survival
3 months
|
86.05 percentage of patents progression free
|
|
Determine Progressive Free Survival
6 months
|
67.44 percentage of patents progression free
|
|
Determine Progressive Free Survival
12 months
|
62.62 percentage of patents progression free
|
|
Determine Progressive Free Survival
24 months
|
51.83 percentage of patents progression free
|
POST_HOC outcome
Timeframe: From the start of treatment and then every 3 months until death or a maximum of 24 months.Population: 1 patient was registered to the study, but was not treated on study and was therefore not evaluable. Data for overall surivival was collected at 3 months, 6 months, 12 months and 24 months. There was no further data analysis completed
Outcome measures
| Measure |
Induction, Combination and Surgery
n=43 Participants
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Overall Survival
3 months
|
93.02 percentage of patients alive
|
|
Overall Survival
6 months
|
83.72 percentage of patients alive
|
|
Overall Survival
12 months
|
66.81 percentage of patients alive
|
|
Overall Survival
24 months
|
58.51 percentage of patients alive
|
Adverse Events
Induction and Combination Treatment
Serious events: 10 serious events
Other events: 43 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Induction and Combination Treatment
n=43 participants at risk
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Cardiac disorders
Supraventricular and nodal arrhythmia:Supraventricular tachycardia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
Cardiac general:Congestive heart failure
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA: Cardiac arrest (Supraventricular and nodal arrhythmia: Atrial fibrillation)
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Infections and infestations
Cellulitis (skin infection)
|
2.3%
1/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Social circumstances
Suicide
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
Other adverse events
| Measure |
Induction and Combination Treatment
n=43 participants at risk
Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6:
Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle.
Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12:
Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
4-6 weeks later subjects will undergo evaluation for response and surgical resection.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin (Anemia)
|
55.8%
24/43 • Number of events 24 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Blood and lymphatic system disorders
Neutrophils (Neutropenia)
|
18.6%
8/43 • Number of events 8 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Blood and lymphatic system disorders
Leukocytes (total white blood count)
|
51.2%
22/43 • Number of events 22 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
46.5%
20/43 • Number of events 20 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Blood and lymphatic system disorders
Platelets (Thrombocytopenia)
|
65.1%
28/43 • Number of events 28 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
Hypotension
|
18.6%
8/43 • Number of events 8 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
Palpitations
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: multifocal atrial tachycardia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia:Tachycardia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Fatigue
|
76.7%
33/43 • Number of events 33 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Fever
|
14.0%
6/43 • Number of events 6 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Insomnia
|
7.0%
3/43 • Number of events 3 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Rigors
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Sweating
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Weight loss
|
32.6%
14/43 • Number of events 14 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Cardiac disorders
cardiac
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Investigations
(International Normalized Ratio of prothrombin time)
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Skin and subcutaneous tissue disorders
Skin
|
27.9%
12/43 • Number of events 12 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Anorexia
|
39.5%
17/43 • Number of events 17 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Ascites
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Constipation
|
25.6%
11/43 • Number of events 11 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Colitis
|
9.3%
4/43 • Number of events 4 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Dehydration
|
34.9%
15/43 • Number of events 15 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
51.2%
22/43 • Number of events 22 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Esophagitis
|
14.0%
6/43 • Number of events 6 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
23.3%
10/43 • Number of events 10 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Heartburn (dyspepsia)
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Nausea
|
65.1%
28/43 • Number of events 28 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Vomiting
|
39.5%
17/43 • Number of events 17 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Difficulty swallowing (dysphagia)
|
37.2%
16/43 • Number of events 16 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Nose bleed
|
7.0%
3/43 • Number of events 3 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Infections and infestations
Infection (not otherwise specified)
|
9.3%
4/43 • Number of events 4 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Infections and infestations
Colitis, infectious
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Infections and infestations
Pulmonary infection
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Infections and infestations
Upper airway infection (not otherwise specified)
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Infections and infestations
Infection (Sepsis)
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase (increase)
|
11.6%
5/43 • Number of events 5 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
ALT/SGPT - serum glutamic pyruvic transaminase (increase)
|
11.6%
5/43 • Number of events 5 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
AST/SGOT -serum glutamic oxaloacetic transaminase (increase)
|
16.3%
7/43 • Number of events 7 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
9.3%
4/43 • Number of events 4 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
11.6%
5/43 • Number of events 5 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Creatinine (increase)
|
7.0%
3/43 • Number of events 3 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
23.3%
10/43 • Number of events 10 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Potassium, serum-low(hypokalemia)
|
14.0%
6/43 • Number of events 6 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Metabolism and nutrition disorders
Sodium, serum-low(hyponatremia)
|
7.0%
3/43 • Number of events 3 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Nervous system disorders
Neuropathy: motor
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Nervous system disorders
Neuropathy: sensory
|
62.8%
27/43 • Number of events 27 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Psychiatric disorders
Confusion
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Psychiatric disorders
Dizziness
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Nervous system disorders
Cold sensitivity
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Psychiatric disorders
Mood alteration - Depression
|
4.7%
2/43 • Number of events 2 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Esophagus pain
|
9.3%
4/43 • Number of events 4 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Gastrointestinal disorders
Abdomen pain (Not otherwise specified)
|
16.3%
7/43 • Number of events 7 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain NOS
|
14.0%
6/43 • Number of events 6 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
General disorders
Pain swallowing (Odynophagia)
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43 • Number of events 3 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath (dyspnea)
|
23.3%
10/43 • Number of events 10 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
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Vascular disorders
Thrombosis
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9.3%
4/43 • Number of events 4 • Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place