Trial Outcomes & Findings for S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction (NCT NCT00086996)
NCT ID: NCT00086996
Last Updated: 2013-10-11
Results Overview
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
10-16 weeks after beginning study treatment
Results posted on
2013-10-11
Participant Flow
Participant milestones
| Measure |
Chemo Plus RT, Surgery, Chemo
* Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m\^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m\^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.
* Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
* Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m\^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m\^2/day by 24-hour infusion continuously on days 1-36.
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
Eligible
|
93
|
|
Overall Study
Eligible and Began Protocol Therapy
|
93
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Chemo Plus RT, Surgery, Chemo
* Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m\^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m\^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.
* Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
* Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m\^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m\^2/day by 24-hour infusion continuously on days 1-36.
|
|---|---|
|
Overall Study
Adverse Event
|
29
|
|
Overall Study
Death
|
4
|
|
Overall Study
progression/relapse
|
7
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Other
|
6
|
|
Overall Study
not eligible
|
5
|
Baseline Characteristics
S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
Baseline characteristics by cohort
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 Participants
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Age Continuous
|
62.2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10-16 weeks after beginning study treatmentPopulation: Eligible patients
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
Outcome measures
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 Participants
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Pathological Complete Response
|
26 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 Participants
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Weight loss
|
13 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Wound complication, non-infectious
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Adult respiratory distress syndrome (ARDS)
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
15 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
CNS cerebrovascular ischemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Calcium, serum-low (hypocalcemia)
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac troponin T (cTnT)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac-ischemia/infarction
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Chyle or lymph leakage
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Confusion
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cough
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Creatinine
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
12 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Distention/bloating, abdominal
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dysphagia (difficulty swallowing)
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Esophagitis
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
14 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fistula, GI - Oral cavity
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Gastrointestinal-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Heartburn/dyspepsia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypotension
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
6 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Blood
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Lung (pneumonia)
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Wound
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leak (including anastomotic), GI - Esophagus
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
10 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mood alteration - anxiety
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Esophagus
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Oral cavity
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Esophagus
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Oral cav
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Nausea
|
11 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Necrosis, GI - Stomach
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Obstruction, GI - Esophagus
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Pain NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pericardial effusion (non-malignant)
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelets
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pleural effusion (non-malignant)
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
4 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pulmonary/Upper Respiratory-Other (Specify)
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Renal failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - Atrial fibrillation
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - Sinus tachycardia
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Skin breakdown/decubitus ulcer
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
5 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Stricture/stenosis (incl anastomotic), Esophagus
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Syncope (fainting)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Typhlitis (cecal inflammation)
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vomiting
|
7 Participants
|
SECONDARY outcome
Timeframe: 0-5 yearsPopulation: eligible patients
Measured from time of registration to death, or last contact date
Outcome measures
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 Participants
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Overall Survival
|
28.3 months
Interval 22.4 to 52.4
|
SECONDARY outcome
Timeframe: 0-3 yearsPopulation: eligible patients
measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.
Outcome measures
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 Participants
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Progression-free Survival
|
19.7 months
Interval 14.7 to 28.3
|
Adverse Events
Chemo Plus RT, Surgery, Chemo
Serious events: 7 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 participants at risk
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
1.1%
1/93 • Up to 3 years
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
1.1%
1/93 • Up to 3 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
1.1%
1/93 • Up to 3 years
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
1.1%
1/93 • Up to 3 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
1.1%
1/93 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
1.1%
1/93 • Up to 3 years
|
|
Investigations
Cardiac troponin I (cTnI)
|
1.1%
1/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
2.2%
2/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
2/93 • Up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.1%
1/93 • Up to 3 years
|
Other adverse events
| Measure |
Chemo Plus RT, Surgery, Chemo
n=93 participants at risk
Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
72.0%
67/93 • Up to 3 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
17.2%
16/93 • Up to 3 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
8.6%
8/93 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
30.1%
28/93 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
63.4%
59/93 • Up to 3 years
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
5.4%
5/93 • Up to 3 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
43.0%
40/93 • Up to 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
10.8%
10/93 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
5.4%
5/93 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
8.6%
8/93 • Up to 3 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
19.4%
18/93 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Esophagus
|
5.4%
5/93 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
19.4%
18/93 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Esophagus
|
17.2%
16/93 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
14.0%
13/93 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
81.7%
76/93 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
14.0%
13/93 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Esophagus
|
18.3%
17/93 • Up to 3 years
|
|
Gastrointestinal disorders
Stricture/stenosis (incl anastomotic), Esophagus
|
7.5%
7/93 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
45.2%
42/93 • Up to 3 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
82.8%
77/93 • Up to 3 years
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
20.4%
19/93 • Up to 3 years
|
|
General disorders
Pain - Chest/thorax NOS
|
9.7%
9/93 • Up to 3 years
|
|
General disorders
Pain-Other (Specify)
|
7.5%
7/93 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
5.4%
5/93 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
8.6%
8/93 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Leak (including anastomotic), GI - Esophagus
|
5.4%
5/93 • Up to 3 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
18.3%
17/93 • Up to 3 years
|
|
Investigations
AST, SGOT
|
17.2%
16/93 • Up to 3 years
|
|
Investigations
Alkaline phosphatase
|
24.7%
23/93 • Up to 3 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
11.8%
11/93 • Up to 3 years
|
|
Investigations
Creatinine
|
11.8%
11/93 • Up to 3 years
|
|
Investigations
Leukocytes (total WBC)
|
39.8%
37/93 • Up to 3 years
|
|
Investigations
Lymphopenia
|
16.1%
15/93 • Up to 3 years
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
6.5%
6/93 • Up to 3 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
12.9%
12/93 • Up to 3 years
|
|
Investigations
Platelets
|
46.2%
43/93 • Up to 3 years
|
|
Investigations
Weight loss
|
57.0%
53/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
33.3%
31/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
60.2%
56/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
31.2%
29/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
26.9%
25/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
38.7%
36/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
6.5%
6/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
5.4%
5/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
24.7%
23/93 • Up to 3 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
31.2%
29/93 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.4%
5/93 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
6.5%
6/93 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
14.0%
13/93 • Up to 3 years
|
|
Nervous system disorders
Neuropathy: sensory
|
59.1%
55/93 • Up to 3 years
|
|
Nervous system disorders
Pain - Head/headache
|
5.4%
5/93 • Up to 3 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
15.1%
14/93 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
10.8%
10/93 • Up to 3 years
|
|
Psychiatric disorders
Mood alteration - anxiety
|
11.8%
11/93 • Up to 3 years
|
|
Psychiatric disorders
Mood alteration - depression
|
14.0%
13/93 • Up to 3 years
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.4%
5/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
10.8%
10/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.4%
19/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.0%
13/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.8%
11/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
14.0%
13/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
8.6%
8/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
8.6%
8/93 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
5.4%
5/93 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.7%
9/93 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
9.7%
9/93 • Up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.4%
5/93 • Up to 3 years
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place