Trial Outcomes & Findings for Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer (NCT NCT00052910)
NCT ID: NCT00052910
Last Updated: 2020-05-07
Results Overview
Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
546 participants
Primary outcome timeframe
From study enrollment until death from any cause; up to 3 years
Results posted on
2020-05-07
Participant Flow
Participant milestones
| Measure |
Arm I (5-FU/LV)
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Arm II (ECF)
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
|
|---|---|---|
|
Overall Study
STARTED
|
280
|
266
|
|
Overall Study
COMPLETED
|
280
|
266
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (5-FU/LV)
n=280 Participants
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Arm II (ECF)
n=266 Participants
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
|
Total
n=546 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
58.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
259 participants
n=5 Participants
|
249 participants
n=7 Participants
|
508 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From study enrollment until death from any cause; up to 3 yearsOverall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm I (5-FU/LV)
n=280 Participants
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Arm II (ECF)
n=266 Participants
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
|
|---|---|---|
|
Overall Survival
|
3.6 years
Interval 2.8 to 4.9
|
3.5 years
Interval 2.5 to 5.0
|
SECONDARY outcome
Timeframe: From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 yearsDisease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm I (5-FU/LV)
n=280 Participants
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Arm II (ECF)
n=266 Participants
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
|
|---|---|---|
|
Disease Free Survival
|
2.7 years
Interval 1.9 to 3.8
|
2.3 years
Interval 1.5 to 3.1
|
Adverse Events
Arm I (5-FU/LV)
Serious events: 62 serious events
Other events: 258 other events
Deaths: 11 deaths
Arm II (ECF)
Serious events: 42 serious events
Other events: 234 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm I (5-FU/LV)
n=272 participants at risk
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Arm II (ECF)
n=251 participants at risk
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
7/272 • Number of events 8
|
0.00%
0/251
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.6%
7/272 • Number of events 7
|
3.2%
8/251 • Number of events 10
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
|
Cardiac disorders
Atrial tachycardia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Cardiac disorder
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Cardiac disorders
Edema
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Sinus bradycardia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Sinus tachycardia
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Eye disorders
Diplopia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Eye disorders
Eye disorder
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Eye disorders
Vision blurred
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Gastrointestinal disorders
Abdominal pain
|
9.9%
27/272 • Number of events 29
|
3.6%
9/251 • Number of events 9
|
|
Gastrointestinal disorders
Ascites
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Gastrointestinal disorders
Colitis
|
1.8%
5/272 • Number of events 5
|
0.00%
0/251
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.74%
2/272 • Number of events 2
|
1.2%
3/251 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
11.4%
31/272 • Number of events 32
|
4.0%
10/251 • Number of events 11
|
|
Gastrointestinal disorders
Dyspepsia
|
0.74%
2/272 • Number of events 2
|
1.6%
4/251 • Number of events 4
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
6/272 • Number of events 6
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia-esophageal related to radiation
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
1.8%
5/272 • Number of events 5
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.8%
5/272 • Number of events 5
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/272
|
1.2%
3/251 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
9.6%
26/272 • Number of events 27
|
2.0%
5/251 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
14.7%
40/272 • Number of events 41
|
7.6%
19/251 • Number of events 20
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
22/272 • Number of events 24
|
6.0%
15/251 • Number of events 16
|
|
General disorders
Chest pain
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
General disorders
Chills
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Death NOS
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Esophagus- Late RT Morbidity Scoring
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
General disorders
Fatigue
|
11.8%
32/272 • Number of events 35
|
10.0%
25/251 • Number of events 28
|
|
General disorders
Fever
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 3
|
|
General disorders
Heart- Late RT Morbidity Scoring
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
General disorders
Joint- Late RT Morbidity Scoring
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Lung-Late RT Morbidity Scoring
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Mucous membrane-Late RT Morbidity Scoring
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
General disorders
Pain
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.74%
2/272 • Number of events 2
|
1.6%
4/251 • Number of events 4
|
|
Infections and infestations
Infection
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
1.1%
3/272 • Number of events 3
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
1.5%
4/272 • Number of events 4
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Amylase increased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Investigations
Aspartate aminotransferase increased
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
1.1%
3/272 • Number of events 3
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Creatinine increased
|
2.6%
7/272 • Number of events 7
|
1.2%
3/251 • Number of events 3
|
|
Investigations
INR increased
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
8.8%
24/272 • Number of events 25
|
7.6%
19/251 • Number of events 21
|
|
Investigations
Lymphocyte count decreased
|
1.8%
5/272 • Number of events 5
|
1.6%
4/251 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
9.2%
25/272 • Number of events 26
|
8.0%
20/251 • Number of events 22
|
|
Investigations
Platelet count decreased
|
5.1%
14/272 • Number of events 15
|
3.6%
9/251 • Number of events 10
|
|
Investigations
Serum cholesterol increased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Investigations
Weight gain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Weight loss
|
2.2%
6/272 • Number of events 6
|
2.8%
7/251 • Number of events 7
|
|
Metabolism and nutrition disorders
Acidosis
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
9.9%
27/272 • Number of events 29
|
6.4%
16/251 • Number of events 18
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
1.8%
5/272 • Number of events 5
|
1.2%
3/251 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
16/272 • Number of events 16
|
3.6%
9/251 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
2.2%
6/272 • Number of events 6
|
0.80%
2/251 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
1.1%
3/272 • Number of events 3
|
1.6%
4/251 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
4.0%
11/272 • Number of events 12
|
1.2%
3/251 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Nervous system disorders
Dysgeusia
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.5%
4/272 • Number of events 4
|
0.00%
0/251
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Memory impairment
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Neurological disorder NOS
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
6/272 • Number of events 6
|
1.6%
4/251 • Number of events 4
|
|
Nervous system disorders
Speech disorder
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Syncope
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/272
|
0.40%
1/251 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
4/272 • Number of events 4
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
2.6%
7/272 • Number of events 7
|
0.80%
2/251 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
1.1%
3/272 • Number of events 3
|
0.00%
0/251
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.6%
7/272 • Number of events 8
|
1.6%
4/251 • Number of events 4
|
|
Vascular disorders
Thrombosis
|
0.37%
1/272 • Number of events 1
|
1.2%
3/251 • Number of events 3
|
Other adverse events
| Measure |
Arm I (5-FU/LV)
n=272 participants at risk
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
|
Arm II (ECF)
n=251 participants at risk
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
|
|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/272
|
0.40%
1/251 • Number of events 3
|
|
Renal and urinary disorders
Urine discoloration
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.5%
4/272 • Number of events 7
|
0.80%
2/251 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
25/272 • Number of events 35
|
7.2%
18/251 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
9/272 • Number of events 13
|
2.8%
7/251 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.2%
6/272 • Number of events 8
|
2.0%
5/251 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
8/272 • Number of events 9
|
2.8%
7/251 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.37%
1/272 • Number of events 1
|
2.8%
7/251 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.1%
3/272 • Number of events 3
|
1.6%
4/251 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
1/272 • Number of events 1
|
2.0%
5/251 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.74%
2/272 • Number of events 4
|
0.40%
1/251 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.5%
4/272 • Number of events 4
|
1.2%
3/251 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.74%
2/272 • Number of events 3
|
0.00%
0/251
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.1%
3/272 • Number of events 6
|
0.80%
2/251 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
21/272 • Number of events 37
|
19.5%
49/251 • Number of events 104
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.37%
1/272 • Number of events 3
|
0.00%
0/251
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.74%
2/272 • Number of events 4
|
0.40%
1/251 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
10/272 • Number of events 11
|
3.2%
8/251 • Number of events 10
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
29.4%
80/272 • Number of events 165
|
32.3%
81/251 • Number of events 180
|
|
Blood and lymphatic system disorders
Hemoglobin for leukemia studies
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/272
|
2.4%
6/251 • Number of events 6
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Conduction disorder
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Edema
|
1.8%
5/272 • Number of events 5
|
0.80%
2/251 • Number of events 2
|
|
Cardiac disorders
Myocardial ischemia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Palpitations
|
0.37%
1/272 • Number of events 2
|
0.00%
0/251
|
|
Cardiac disorders
Pericarditis
|
0.37%
1/272 • Number of events 4
|
0.00%
0/251
|
|
Cardiac disorders
Sinus bradycardia
|
0.37%
1/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
1.5%
4/272 • Number of events 4
|
0.40%
1/251 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/272
|
1.2%
3/251 • Number of events 3
|
|
Ear and labyrinth disorders
Hearing test abnormal
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
Eye disorders
Dry eye syndrome
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Eye disorders
Eye disorder
|
1.1%
3/272 • Number of events 6
|
0.80%
2/251 • Number of events 3
|
|
Eye disorders
Flashing vision
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.74%
2/272 • Number of events 3
|
0.40%
1/251 • Number of events 1
|
|
Eye disorders
Watering eyes
|
0.74%
2/272 • Number of events 3
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
40.1%
109/272 • Number of events 186
|
37.5%
94/251 • Number of events 141
|
|
Gastrointestinal disorders
Ascites
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
1.5%
4/272 • Number of events 5
|
0.00%
0/251
|
|
Gastrointestinal disorders
Constipation
|
13.6%
37/272 • Number of events 54
|
15.9%
40/251 • Number of events 59
|
|
Gastrointestinal disorders
Diarrhea
|
59.6%
162/272 • Number of events 313
|
47.8%
120/251 • Number of events 227
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
4/272 • Number of events 6
|
2.0%
5/251 • Number of events 6
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
18/272 • Number of events 24
|
8.4%
21/251 • Number of events 35
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
24/272 • Number of events 29
|
9.2%
23/251 • Number of events 37
|
|
Gastrointestinal disorders
Dysphagia-esophageal related to radiation
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Gastrointestinal disorders
Esophagitis
|
4.0%
11/272 • Number of events 14
|
5.2%
13/251 • Number of events 15
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
10/272 • Number of events 13
|
1.6%
4/251 • Number of events 9
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
7/272 • Number of events 8
|
2.8%
7/251 • Number of events 9
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.9%
8/272 • Number of events 9
|
2.8%
7/251 • Number of events 8
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.37%
1/272 • Number of events 3
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis due to radiation
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
57.0%
155/272 • Number of events 248
|
42.6%
107/251 • Number of events 168
|
|
Gastrointestinal disorders
Nausea
|
70.6%
192/272 • Number of events 390
|
70.1%
176/251 • Number of events 425
|
|
Gastrointestinal disorders
Oral pain
|
1.5%
4/272 • Number of events 4
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Gastrointestinal disorders
Proctitis
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/272
|
0.40%
1/251 • Number of events 4
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/272
|
1.2%
3/251 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
45.2%
123/272 • Number of events 191
|
47.8%
120/251 • Number of events 209
|
|
General disorders
Bladder- Late RT Morbidity Scoring
|
0.00%
0/272
|
1.2%
3/251 • Number of events 3
|
|
General disorders
Bone - Late RT Morbidity Scoring
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
General disorders
Brain- Late RT Morbidity Scoring
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
General disorders
Chest pain
|
1.8%
5/272 • Number of events 7
|
3.2%
8/251 • Number of events 10
|
|
General disorders
Chills
|
1.1%
3/272 • Number of events 5
|
1.2%
3/251 • Number of events 4
|
|
General disorders
Edema limbs
|
1.1%
3/272 • Number of events 3
|
2.8%
7/251 • Number of events 10
|
|
General disorders
Esophagus- Late RT Morbidity Scoring
|
7.0%
19/272 • Number of events 63
|
7.6%
19/251 • Number of events 32
|
|
General disorders
Facial pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Fatigue
|
73.9%
201/272 • Number of events 493
|
75.7%
190/251 • Number of events 503
|
|
General disorders
Fever
|
3.7%
10/272 • Number of events 11
|
2.4%
6/251 • Number of events 6
|
|
General disorders
Flu-like symptoms
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
General disorders
General symptom
|
0.74%
2/272 • Number of events 2
|
1.2%
3/251 • Number of events 4
|
|
General disorders
Heart- Late RT Morbidity Scoring
|
1.1%
3/272 • Number of events 4
|
1.6%
4/251 • Number of events 7
|
|
General disorders
Ill-defined disorder
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Joint- Late RT Morbidity Scoring
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Kidney-Late RT Morbidity Scoring
|
1.1%
3/272 • Number of events 3
|
1.2%
3/251 • Number of events 6
|
|
General disorders
Larynx-Late RT Morbidity Scoring
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 2
|
|
General disorders
Liver-Late RT Morbidity Scoring
|
2.2%
6/272 • Number of events 17
|
1.6%
4/251 • Number of events 7
|
|
General disorders
Localized edema
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Lung-Late RT Morbidity Scoring
|
2.9%
8/272 • Number of events 11
|
2.4%
6/251 • Number of events 14
|
|
General disorders
Mucous membrane-Late RT Morbidity Scoring
|
1.1%
3/272 • Number of events 3
|
1.6%
4/251 • Number of events 5
|
|
General disorders
Pain
|
7.0%
19/272 • Number of events 31
|
9.2%
23/251 • Number of events 32
|
|
General disorders
Pericardial pain
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Radiation-Other(Specify,_____)
|
6.2%
17/272 • Number of events 24
|
4.4%
11/251 • Number of events 28
|
|
General disorders
Salivary glands-Late RT Morbidity Scoring
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
General disorders
Skin-Late RT Morbidity Scoring
|
2.2%
6/272 • Number of events 6
|
1.2%
3/251 • Number of events 3
|
|
General disorders
Small/Large intestine-Late RT Morbidity Scoring
|
4.4%
12/272 • Number of events 16
|
4.8%
12/251 • Number of events 23
|
|
General disorders
Subcutaneous tissue-Late RT Morbidity Scoring
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.1%
3/272 • Number of events 6
|
0.40%
1/251 • Number of events 1
|
|
Hepatobiliary disorders
Portal hypertension
|
0.37%
1/272 • Number of events 2
|
0.00%
0/251
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Infections and infestations
Bladder infection
|
0.74%
2/272 • Number of events 4
|
0.00%
0/251
|
|
Infections and infestations
Bronchitis
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.37%
1/272 • Number of events 2
|
2.0%
5/251 • Number of events 6
|
|
Infections and infestations
Device related infection
|
0.37%
1/272 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
|
Infections and infestations
Esophageal infection
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Infections and infestations
Infection
|
3.7%
10/272 • Number of events 13
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
1.5%
4/272 • Number of events 4
|
0.80%
2/251 • Number of events 3
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
2.2%
6/272 • Number of events 6
|
2.8%
7/251 • Number of events 7
|
|
Infections and infestations
Infectious colitis
|
1.1%
3/272 • Number of events 3
|
0.00%
0/251
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/272
|
0.80%
2/251 • Number of events 3
|
|
Infections and infestations
Paranasal sinus infection
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Penile infection
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/272
|
0.80%
2/251 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 3
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Infections and infestations
Ureteritis
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
Infections and infestations
Wound infection
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 3
|
|
Infections and infestations
Wound-infectious
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
8.5%
23/272 • Number of events 26
|
6.4%
16/251 • Number of events 21
|
|
Injury, poisoning and procedural complications
Fracture
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Appendix
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.1%
3/272 • Number of events 3
|
0.40%
1/251 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/272
|
0.40%
1/251 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.5%
4/272 • Number of events 4
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
21/272 • Number of events 34
|
8.8%
22/251 • Number of events 36
|
|
Investigations
Alkaline phosphatase
|
1.5%
4/272 • Number of events 8
|
2.0%
5/251 • Number of events 7
|
|
Investigations
Alkaline phosphatase increased
|
8.1%
22/272 • Number of events 32
|
6.8%
17/251 • Number of events 23
|
|
Investigations
Amylase increased
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
13.2%
36/272 • Number of events 54
|
11.2%
28/251 • Number of events 36
|
|
Investigations
Blood bilirubin increased
|
5.9%
16/272 • Number of events 22
|
2.8%
7/251 • Number of events 8
|
|
Investigations
Coagulopathy
|
1.8%
5/272 • Number of events 6
|
0.00%
0/251
|
|
Investigations
Creatine phosphokinase increased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Investigations
Creatinine increased
|
8.1%
22/272 • Number of events 29
|
6.8%
17/251 • Number of events 34
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.74%
2/272 • Number of events 4
|
0.80%
2/251 • Number of events 4
|
|
Investigations
Haptoglobin decreased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Investigations
INR increased
|
1.5%
4/272 • Number of events 5
|
0.80%
2/251 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
1.1%
3/272 • Number of events 5
|
1.6%
4/251 • Number of events 4
|
|
Investigations
Leukocyte count decreased
|
65.1%
177/272 • Number of events 409
|
70.5%
177/251 • Number of events 458
|
|
Investigations
Lipase increased
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
14.3%
39/272 • Number of events 75
|
12.7%
32/251 • Number of events 67
|
|
Investigations
Neutrophil count decreased
|
65.4%
178/272 • Number of events 333
|
66.1%
166/251 • Number of events 361
|
|
Investigations
Platelet count decreased
|
33.8%
92/272 • Number of events 167
|
29.5%
74/251 • Number of events 145
|
|
Investigations
Weight gain
|
0.00%
0/272
|
1.2%
3/251 • Number of events 3
|
|
Investigations
Weight loss
|
21.7%
59/272 • Number of events 96
|
20.3%
51/251 • Number of events 90
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/272
|
0.40%
1/251 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
54.4%
148/272 • Number of events 279
|
55.8%
140/251 • Number of events 294
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
15.1%
41/272 • Number of events 66
|
18.7%
47/251 • Number of events 77
|
|
Metabolism and nutrition disorders
Dehydration
|
12.1%
33/272 • Number of events 45
|
12.4%
31/251 • Number of events 45
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.8%
32/272 • Number of events 40
|
11.2%
28/251 • Number of events 44
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
10.3%
28/272 • Number of events 38
|
9.2%
23/251 • Number of events 28
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.8%
5/272 • Number of events 8
|
4.0%
10/251 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
1.8%
5/272 • Number of events 7
|
4.0%
10/251 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.74%
2/272 • Number of events 2
|
1.2%
3/251 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
11.4%
31/272 • Number of events 44
|
10.4%
26/251 • Number of events 43
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.6%
7/272 • Number of events 8
|
1.6%
4/251 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
8.8%
24/272 • Number of events 32
|
5.6%
14/251 • Number of events 24
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.74%
2/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
8/272 • Number of events 14
|
2.4%
6/251 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
7/272 • Number of events 12
|
4.4%
11/251 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.5%
4/272 • Number of events 5
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.37%
1/272 • Number of events 1
|
1.2%
3/251 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.5%
4/272 • Number of events 5
|
0.80%
2/251 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.37%
1/272 • Number of events 2
|
0.80%
2/251 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
7/272 • Number of events 8
|
1.6%
4/251 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.37%
1/272 • Number of events 3
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.37%
1/272 • Number of events 1
|
2.0%
5/251 • Number of events 7
|
|
Nervous system disorders
Ataxia
|
0.74%
2/272 • Number of events 2
|
0.80%
2/251 • Number of events 2
|
|
Nervous system disorders
Depressed level of consciousness
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Dizziness
|
5.5%
15/272 • Number of events 18
|
8.8%
22/251 • Number of events 33
|
|
Nervous system disorders
Dysgeusia
|
9.9%
27/272 • Number of events 41
|
8.0%
20/251 • Number of events 39
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.8%
13/272 • Number of events 17
|
6.8%
17/251 • Number of events 23
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/272
|
0.40%
1/251 • Number of events 2
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/272
|
0.80%
2/251 • Number of events 4
|
|
Nervous system disorders
Neurological disorder NOS
|
0.74%
2/272 • Number of events 4
|
0.00%
0/251
|
|
Nervous system disorders
Neuropathy - cranial
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.74%
2/272 • Number of events 2
|
2.0%
5/251 • Number of events 6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
34/272 • Number of events 55
|
15.1%
38/251 • Number of events 62
|
|
Nervous system disorders
Syncope
|
1.1%
3/272 • Number of events 3
|
1.6%
4/251 • Number of events 4
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/272
|
1.2%
3/251 • Number of events 3
|
|
Nervous system disorders
Tremor
|
0.74%
2/272 • Number of events 3
|
1.2%
3/251 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
1.8%
5/272 • Number of events 7
|
4.8%
12/251 • Number of events 27
|
|
Psychiatric disorders
Depression
|
3.3%
9/272 • Number of events 13
|
7.2%
18/251 • Number of events 29
|
|
Psychiatric disorders
Euphoria
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Psychiatric disorders
Insomnia
|
6.2%
17/272 • Number of events 22
|
6.4%
16/251 • Number of events 23
|
|
Psychiatric disorders
Libido decreased
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Renal and urinary disorders
Bladder pain
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 2
|
|
Renal and urinary disorders
Incontinence
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/272
|
0.80%
2/251 • Number of events 2
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
1.1%
3/272 • Number of events 3
|
1.6%
4/251 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dermatology
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
9/272 • Number of events 12
|
2.4%
6/251 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.37%
1/272 • Number of events 3
|
0.40%
1/251 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
13.2%
36/272 • Number of events 52
|
18.3%
46/251 • Number of events 75
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.5%
4/272 • Number of events 4
|
5.6%
14/251 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/272
|
0.40%
1/251 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
0.00%
0/272
|
0.80%
2/251 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
6/272 • Number of events 11
|
1.6%
4/251 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.37%
1/272 • Number of events 2
|
0.40%
1/251 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
11.0%
30/272 • Number of events 39
|
5.2%
13/251 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.6%
7/272 • Number of events 10
|
1.2%
3/251 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.8%
5/272 • Number of events 8
|
2.8%
7/251 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.74%
2/272 • Number of events 2
|
2.4%
6/251 • Number of events 7
|
|
Vascular disorders
Flushing
|
1.5%
4/272 • Number of events 7
|
0.80%
2/251 • Number of events 3
|
|
Vascular disorders
Hemorrhage
|
0.74%
2/272 • Number of events 2
|
0.00%
0/251
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
0.37%
1/272 • Number of events 1
|
0.40%
1/251 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.37%
1/272 • Number of events 1
|
0.80%
2/251 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/272
|
1.6%
4/251 • Number of events 5
|
|
Vascular disorders
Hypotension
|
2.6%
7/272 • Number of events 10
|
4.4%
11/251 • Number of events 14
|
|
Vascular disorders
Phlebitis
|
0.37%
1/272 • Number of events 1
|
0.00%
0/251
|
|
Vascular disorders
Thrombosis
|
2.2%
6/272 • Number of events 7
|
4.0%
10/251 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place