Trial Outcomes & Findings for Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix (NCT NCT01580410)
NCT ID: NCT01580410
Last Updated: 2018-07-03
Results Overview
If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Within 4 weeks of surgery
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
Arm I (Mitomycin C)
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgery and Oxaliplatin or Mitomycin C in Treating Patients With Tumors of the Appendix
Baseline characteristics by cohort
| Measure |
Arm I (Mitomycin C)
n=68 Participants
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=68 Participants
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 4 weeks of surgeryIf a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.
Outcome measures
| Measure |
Arm I (Mitomycin C)
n=61 Participants
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=59 Participants
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments
|
8 number of patients with toxicities
|
5 number of patients with toxicities
|
SECONDARY outcome
Timeframe: Time to first progression unless the patient's resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 yearsOutcome measures
| Measure |
Arm I (Mitomycin C)
n=57 Participants
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=53 Participants
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years
|
61.6 disease-free survival rate (%)
Standard Error 8.1
|
59.4 disease-free survival rate (%)
Standard Error 8.1
|
SECONDARY outcome
Timeframe: Interval between surgery and death or date of last contact, assessed up to 3 yearsOutcome measures
| Measure |
Arm I (Mitomycin C)
n=57 Participants
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=53 Participants
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years
|
75.7 overall survival rate (%)
Standard Error 6.4
|
79.3 overall survival rate (%)
Standard Error 5.7
|
SECONDARY outcome
Timeframe: Throughout study completion, up to 3 yearsThe FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.
Outcome measures
| Measure |
Arm I (Mitomycin C)
n=57 Participants
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=53 Participants
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)
|
85.5 units on a scale
Standard Error 1.6
|
89.6 units on a scale
Standard Error 1.7
|
Adverse Events
Arm I (Mitomycin C)
Serious events: 51 serious events
Other events: 58 other events
Deaths: 1 deaths
Arm II (Oxaliplatin)
Serious events: 54 serious events
Other events: 61 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm I (Mitomycin C)
n=58 participants at risk
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=61 participants at risk
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
Investigations
Low WBC
|
5.2%
3/58 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
|
Investigations
low Platelets
|
1.7%
1/58 • Number of events 1
|
4.9%
3/61 • Number of events 4
|
|
Investigations
Low Hemoglobin
|
60.3%
35/58 • Number of events 35
|
59.0%
36/61 • Number of events 36
|
|
Gastrointestinal disorders
Nausea
|
12.1%
7/58 • Number of events 7
|
16.4%
10/61 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
5.2%
3/58 • Number of events 3
|
14.8%
9/61 • Number of events 9
|
|
General disorders
Anorexia
|
17.2%
10/58 • Number of events 10
|
13.1%
8/61 • Number of events 8
|
|
Gastrointestinal disorders
Obstruction, GI: Small bowel
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Creatinine
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Renal and urinary disorders
Renal failure
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.0%
11/58 • Number of events 11
|
23.0%
14/61 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.7%
1/58 • Number of events 1
|
8.2%
5/61 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
12.1%
7/58 • Number of events 7
|
13.1%
8/61 • Number of events 8
|
|
Cardiac disorders
Hypotension
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
Investigations
Low ANC
|
1.7%
1/58 • Number of events 1
|
6.6%
4/61 • Number of events 4
|
|
General disorders
Fatigue
|
10.3%
6/58 • Number of events 6
|
11.5%
7/61 • Number of events 7
|
|
General disorders
Weight loss
|
6.9%
4/58 • Number of events 4
|
3.3%
2/61 • Number of events 2
|
|
Investigations
hyperglycemia
|
5.2%
3/58 • Number of events 3
|
9.8%
6/61 • Number of events 6
|
|
Investigations
hypocalcemia
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Investigations
hyponatremia
|
5.2%
3/58 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
|
Investigations
hypokalemia
|
12.1%
7/58 • Number of events 7
|
1.6%
1/61 • Number of events 1
|
|
Investigations
hypoalbuminemia
|
27.6%
16/58 • Number of events 16
|
31.1%
19/61 • Number of events 19
|
|
Investigations
hyperbilirubinemia
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Investigations
serum glutamic pyruvic transaminase
|
20.7%
12/58 • Number of events 12
|
14.8%
9/61 • Number of events 9
|
|
Investigations
hypophosphatemia
|
22.4%
13/58 • Number of events 13
|
23.0%
14/61 • Number of events 14
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
27.6%
16/58 • Number of events 16
|
11.5%
7/61 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Dehydration
|
1.7%
1/58 • Number of events 1
|
8.2%
5/61 • Number of events 5
|
|
General disorders
Confusion
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Mood alteration: Agitation
|
6.9%
4/58 • Number of events 4
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Anxiety
|
1.7%
1/58 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Depression
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Pain: Abdomen
|
8.6%
5/58 • Number of events 5
|
6.6%
4/61 • Number of events 4
|
|
Investigations
Acidosis
|
3.4%
2/58 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
2/58 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Infection Bladder
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Investigations
creatine phosphokinase
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Pain: Chest/thorax
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Cystitis
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Investigations
disseminated intravascular coagulation
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Investigations
Prolonged QTc interval
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Gastrointestinal disorders
functional obstruction of bowel
|
13.8%
8/58 • Number of events 8
|
16.4%
10/61 • Number of events 10
|
|
Investigations
Lymphopenia
|
34.5%
20/58 • Number of events 21
|
41.0%
25/61 • Number of events 28
|
|
Gastrointestinal disorders
Malabsorption
|
3.4%
2/58 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
|
General disorders
Death not associated with CTCAE term: Multi-organ failure
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Pain: Muscle
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
Infections and infestations
infection associated with Lymphopenia
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain: Skin
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Lung infection
|
15.5%
9/58 • Number of events 9
|
16.4%
10/61 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Investigations
International Normalized Ratio of prothrombin time
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Pain: Scrotum
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/58 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Urinary with low grade neutropenia
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
General disorders
Mental status
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Vascular disorders
Hemorrhage, GI: Lower GI
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen
|
5.2%
3/58 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Peritoneal cavity
|
3.4%
2/58 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Cardiac troponin I
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Gastrointestinal disorders
Fistula, GI: Abdomen
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Gastrointestinal disorders
Leak (including anastomotic), GI: Leak
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Leak (including anastomotic), GI: Small bowel
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Gastrointestinal disorders
Necrosis, GI: Small bowel
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Lung Infection with high grade neutropenia
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC: Peritoneal cavity
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
Infections and infestations
Infection with high grade neutropenia
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Blood Infection with high grade neutropenia
|
5.2%
3/58 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
Other adverse events
| Measure |
Arm I (Mitomycin C)
n=58 participants at risk
Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC.
mitomycin C: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
Arm II (Oxaliplatin)
n=61 participants at risk
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
oxaliplatin: Given by HIPEC
therapeutic conventional surgery: Undergo surgery
quality-of-life assessment: Ancillary studies
hyperthermic intraperitoneal chemotherapy: Undergo HIPEC
|
|---|---|---|
|
Investigations
Low WBC
|
19.0%
11/58 • Number of events 11
|
36.1%
22/61 • Number of events 22
|
|
Investigations
low Platelets
|
56.9%
33/58 • Number of events 33
|
44.3%
27/61 • Number of events 27
|
|
Investigations
Low Hemoglobin
|
37.9%
22/58 • Number of events 22
|
36.1%
22/61 • Number of events 22
|
|
Gastrointestinal disorders
Nausea
|
32.8%
19/58 • Number of events 19
|
29.5%
18/61 • Number of events 18
|
|
Gastrointestinal disorders
Vomiting
|
41.4%
24/58 • Number of events 24
|
27.9%
17/61 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
18/58 • Number of events 18
|
13.1%
8/61 • Number of events 8
|
|
General disorders
Anorexia
|
34.5%
20/58 • Number of events 20
|
31.1%
19/61 • Number of events 19
|
|
Investigations
Alkaline phosphatase
|
53.4%
31/58 • Number of events 31
|
44.3%
27/61 • Number of events 27
|
|
Investigations
Creatinine
|
3.4%
2/58 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Investigations
Proteinuria
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.3%
6/58 • Number of events 6
|
4.9%
3/61 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
32.8%
19/58 • Number of events 19
|
16.4%
10/61 • Number of events 10
|
|
General disorders
Hypertension
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
Cardiac disorders
Hypotension
|
13.8%
8/58 • Number of events 8
|
6.6%
4/61 • Number of events 4
|
|
Cardiac disorders
Neuropathy: sensory
|
10.3%
6/58 • Number of events 7
|
1.6%
1/61 • Number of events 1
|
|
Investigations
Low ANC
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
General disorders
Taste alteration
|
6.9%
4/58 • Number of events 4
|
6.6%
4/61 • Number of events 4
|
|
General disorders
Insomnia
|
19.0%
11/58 • Number of events 11
|
8.2%
5/61 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Rigors/chills
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Sweating
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
General disorders
Fatigue
|
51.7%
30/58 • Number of events 30
|
36.1%
22/61 • Number of events 22
|
|
General disorders
Weight loss
|
44.8%
26/58 • Number of events 26
|
55.7%
34/61 • Number of events 34
|
|
Investigations
hyperglycemia
|
72.4%
42/58 • Number of events 42
|
68.9%
42/61 • Number of events 42
|
|
Investigations
hypocalcemia
|
5.2%
3/58 • Number of events 3
|
6.6%
4/61 • Number of events 4
|
|
Investigations
hypomagnesemia
|
13.8%
8/58 • Number of events 8
|
9.8%
6/61 • Number of events 6
|
|
Investigations
hyponatremia
|
60.3%
35/58 • Number of events 35
|
47.5%
29/61 • Number of events 29
|
|
Investigations
hypokalemia
|
44.8%
26/58 • Number of events 26
|
50.8%
31/61 • Number of events 31
|
|
Investigations
Bicarbonate serum-low
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Investigations
hypoalbuminemia
|
56.9%
33/58 • Number of events 33
|
57.4%
35/61 • Number of events 35
|
|
Investigations
hyperbilirubinemia
|
3.4%
2/58 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
|
Investigations
serum glutamic pyruvic transaminase
|
53.4%
31/58 • Number of events 31
|
60.7%
37/61 • Number of events 37
|
|
Investigations
hypophosphatemia
|
8.6%
5/58 • Number of events 5
|
9.8%
6/61 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
10.3%
6/58 • Number of events 6
|
6.6%
4/61 • Number of events 4
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
53.4%
31/58 • Number of events 31
|
70.5%
43/61 • Number of events 43
|
|
Investigations
hypermagnesemia
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Investigations
hyperkalemia
|
3.4%
2/58 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
|
Investigations
hypernatremia
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Dysphagia
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Fever without neutropenia
|
10.3%
6/58 • Number of events 6
|
8.2%
5/61 • Number of events 5
|
|
General disorders
Constitutional Symptoms - Other
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
6/58 • Number of events 6
|
3.3%
2/61 • Number of events 2
|
|
Vascular disorders
Edema: limb
|
3.4%
2/58 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
|
General disorders
Edema: trunk/genital
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Edema: viscera
|
5.2%
3/58 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Dehydration
|
3.4%
2/58 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Confusion
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
General disorders
Mood alteration: Agitation
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Anxiety
|
8.6%
5/58 • Number of events 5
|
6.6%
4/61 • Number of events 4
|
|
General disorders
Depression
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Distension bloating, abdominal
|
6.9%
4/58 • Number of events 4
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Pain: Abdomen
|
13.8%
8/58 • Number of events 8
|
29.5%
18/61 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Pain: Joint
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
34.5%
20/58 • Number of events 20
|
26.2%
16/61 • Number of events 16
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Pain: Back
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Infections and infestations
Infection Bladder
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Pain Bladder
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Right ventricular dysfunction
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Wound complication, non-infectious
|
17.2%
10/58 • Number of events 10
|
13.1%
8/61 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
1.7%
1/58 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematoma
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Hiccoughs (hiccups, singultus)
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Investigations
hypertriglyceridemia
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Gastrointestinal disorders
functional obstruction of bowel
|
8.6%
5/58 • Number of events 5
|
6.6%
4/61 • Number of events 4
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Investigations
Lymphopenia
|
41.4%
24/58 • Number of events 24
|
34.4%
21/61 • Number of events 21
|
|
General disorders
Pain: Muscle
|
6.9%
4/58 • Number of events 4
|
8.2%
5/61 • Number of events 5
|
|
General disorders
Pain: Neuralgia/peripheral nerve
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Pain Oral cavity
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Lung infection
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.2%
3/58 • Number of events 3
|
8.2%
5/61 • Number of events 5
|
|
Investigations
International Normalized Ratio of prothrombin time
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus bradycardia
|
3.4%
2/58 • Number of events 2
|
0.00%
0/61
|
|
Cardiac disorders
Sinus tachycardia
|
15.5%
9/58 • Number of events 9
|
8.2%
5/61 • Number of events 5
|
|
General disorders
Pain: Stomach
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Supraventricular tachycardia
|
1.7%
1/58 • Number of events 1
|
4.9%
3/61 • Number of events 3
|
|
General disorders
Pain: Urethra
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Urinary with low grade neutropenia
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Hemorrhage GU: Urinary
|
5.2%
3/58 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
|
Gastrointestinal disorders
Leak (including anastomotic), GI: Pancreas
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Cognitive disturbance
|
1.7%
1/58 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Leak (including anastomotic), GI: Leak
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
1.7%
1/58 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
3.4%
2/58 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC Lung (pneumonia)
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged chest tube drainage or air leak after pulmonary resection
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Intra-operative injury: NERVES: Peripheral sensory
|
1.7%
1/58 • Number of events 1
|
0.00%
0/61
|
Additional Information
Dr. Edward Levine
Wake Forest University Health Sciences
Phone: 336-716-2763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place