Trial Outcomes & Findings for Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer (NCT NCT00470184)
NCT ID: NCT00470184
Last Updated: 2013-11-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
5.5 weeks
Results posted on
2013-11-25
Participant Flow
Participant milestones
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Treated With Study Therapy
|
36
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Overall Study
Not Treated(became ineligible)
|
4
|
|
Overall Study
Not treated (other)
|
1
|
|
Overall Study
disease Progression
|
4
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
other
|
5
|
|
Overall Study
recurrence
|
1
|
Baseline Characteristics
Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer
Baseline characteristics by cohort
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 Participants
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Age Continuous
|
59.53 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5.5 weeksPopulation: Evaluable Patients
Outcome measures
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 Participants
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Complete Response
|
27.78 percentage of patients
Interval 14.2 to 45.19
|
SECONDARY outcome
Timeframe: 5.5 weeksPopulation: evaluable patients
Outcome measures
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 Participants
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1
|
58.33 percentage of patients
Interval 40.76 to 74.49
|
SECONDARY outcome
Timeframe: 5.5 weeksPopulation: Evaluable patients
Outcome measures
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 Participants
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Median Time to Progression
|
NA months
Interval 25.1 to
NA (not available): median PFS was not reached but is \>69.9 months, as is the upper bound of the 95% CI.
|
SECONDARY outcome
Timeframe: 5.5 weeksPopulation: evaluable patients
Outcome measures
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 Participants
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Quality of Life Improved Rate
|
66.67 percentage of patients
Interval 49.03 to 81.44
|
Adverse Events
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
Serious events: 12 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 participants at risk
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Cardiac disorders
Pericardial effusion - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Pericarditis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal fistula - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal stenosis - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Death - Grade 5
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Fatigue - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Infection - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Wound infection - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic leak - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Platelet count decreased - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis - Grade 4
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism - Grade 4
|
8.3%
3/36 • Number of events 3
|
Other adverse events
| Measure |
COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy
n=36 participants at risk
Cycle 1:
Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia - Grade 1
|
25.0%
9/36 • Number of events 12
|
|
Blood and lymphatic system disorders
Anaemia - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia - Grade 4
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 1
|
44.4%
16/36 • Number of events 43
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 2
|
27.8%
10/36 • Number of events 19
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 3
|
11.1%
4/36 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 1
|
83.3%
30/36 • Number of events 81
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 2
|
91.7%
33/36 • Number of events 114
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 3
|
69.4%
25/36 • Number of events 51
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 4
|
16.7%
6/36 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 2
|
13.9%
5/36 • Number of events 9
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 3
|
5.6%
2/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 1
|
22.2%
8/36 • Number of events 10
|
|
Cardiac disorders
Arrhythmia - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation - Grade 2
|
11.1%
4/36 • Number of events 4
|
|
Cardiac disorders
Palpitations - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Tachycardia - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Eye discharge - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Photopsia - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Vision blurred - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Eye disorders
Visual disturbance - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain - Grade 1
|
25.0%
9/36 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper - Grade 1
|
13.9%
5/36 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Ascites - Grade 2
|
2.8%
1/36 • Number of events 2
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
44.4%
16/36 • Number of events 24
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea - Grade 1
|
63.9%
23/36 • Number of events 54
|
|
Gastrointestinal disorders
Diarrhoea - Grade 2
|
16.7%
6/36 • Number of events 9
|
|
Gastrointestinal disorders
Dry mouth - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
13.9%
5/36 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
22.2%
8/36 • Number of events 9
|
|
Gastrointestinal disorders
Dysphagia - Grade 2
|
13.9%
5/36 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Eructation - Grade 1
|
5.6%
2/36 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Impaired gastric emptying - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
63.9%
23/36 • Number of events 52
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
22.2%
8/36 • Number of events 11
|
|
Gastrointestinal disorders
Odynophagia - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Oesophageal pain - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal stenosis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal stenosis - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis - Grade 1
|
13.9%
5/36 • Number of events 5
|
|
Gastrointestinal disorders
Oesophagitis - Grade 2
|
19.4%
7/36 • Number of events 8
|
|
Gastrointestinal disorders
Pancreatic insufficiency - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
52.8%
19/36 • Number of events 31
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
19.4%
7/36 • Number of events 9
|
|
General disorders
Asthenia - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Asthenia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Chest discomfort - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Chest pain - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Chest pain - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Chills - Grade 1
|
19.4%
7/36 • Number of events 7
|
|
General disorders
Early satiety - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Fatigue - Grade 1
|
75.0%
27/36 • Number of events 49
|
|
General disorders
Fatigue - Grade 2
|
33.3%
12/36 • Number of events 16
|
|
General disorders
Fibrosis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Infusion site reaction - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Injection site pain - Grade 1
|
2.8%
1/36 • Number of events 2
|
|
General disorders
Injection site phlebitis - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Injection site phlebitis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Injection site reaction - Grade 1
|
19.4%
7/36 • Number of events 8
|
|
General disorders
Injection site reaction - Grade 2
|
2.8%
1/36 • Number of events 2
|
|
General disorders
Malaise - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Mucosal inflammation - Grade 1
|
11.1%
4/36 • Number of events 4
|
|
General disorders
Oedema peripheral - Grade 1
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Pain - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Pyrexia - Grade 1
|
16.7%
6/36 • Number of events 6
|
|
General disorders
Pyrexia - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Systemic inflammatory response syndrome - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 1
|
2.8%
1/36 • Number of events 2
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 2
|
8.3%
3/36 • Number of events 5
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 3
|
11.1%
4/36 • Number of events 4
|
|
Immune system disorders
Hypersensitivity - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Infections and infestations
Bronchitis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Candidiasis - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Eye infection - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Fungal infection - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Gastroenteritis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Infection - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Infection - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Infections and infestations
Infection - Grade 3
|
11.1%
4/36 • Number of events 5
|
|
Infections and infestations
Opportunistic infection - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic leak - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Injury, poisoning and procedural complications
Incision site complication - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Alanine aminotransferase - Grade 1
|
11.1%
4/36 • Number of events 4
|
|
Investigations
Alanine aminotransferase - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Investigations
Alanine aminotransferase decreased - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased - Grade 1
|
36.1%
13/36 • Number of events 18
|
|
Investigations
Alanine aminotransferase increased - Grade 2
|
25.0%
9/36 • Number of events 12
|
|
Investigations
Alanine aminotransferase increased - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Aspartate aminotransferase - Grade 1
|
19.4%
7/36 • Number of events 16
|
|
Investigations
Aspartate aminotransferase - Grade 2
|
11.1%
4/36 • Number of events 5
|
|
Investigations
Aspartate aminotransferase - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Aspartate aminotransferase decreased - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased - Grade 1
|
77.8%
28/36 • Number of events 51
|
|
Investigations
Aspartate aminotransferase increased - Grade 2
|
36.1%
13/36 • Number of events 18
|
|
Investigations
Aspartate aminotransferase increased - Grade 3
|
16.7%
6/36 • Number of events 7
|
|
Investigations
Blood albumin decreased - Grade 1
|
11.1%
4/36 • Number of events 6
|
|
Investigations
Blood albumin decreased - Grade 2
|
19.4%
7/36 • Number of events 8
|
|
Investigations
Blood albumin decreased - Grade 3
|
11.1%
4/36 • Number of events 5
|
|
Investigations
Blood alkaline phosphatase - Grade 1
|
38.9%
14/36 • Number of events 27
|
|
Investigations
Blood alkaline phosphatase - Grade 2
|
11.1%
4/36 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase increased - Grade 1
|
25.0%
9/36 • Number of events 9
|
|
Investigations
Blood alkaline phosphatase increased - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood bilirubin - Grade 1
|
11.1%
4/36 • Number of events 4
|
|
Investigations
Blood bilirubin - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood calcium decreased - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Blood calcium decreased - Grade 2
|
13.9%
5/36 • Number of events 5
|
|
Investigations
Blood calcium increased - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood creatine increased - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood creatinine - Grade 1
|
13.9%
5/36 • Number of events 6
|
|
Investigations
Blood creatinine - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood glucose decreased - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Blood glucose increased - Grade 1
|
16.7%
6/36 • Number of events 6
|
|
Investigations
Blood glucose increased - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Blood glucose increased - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Blood potassium decreased - Grade 1
|
11.1%
4/36 • Number of events 4
|
|
Investigations
Blood potassium increased - Grade 1
|
5.6%
2/36 • Number of events 3
|
|
Investigations
Blood potassium increased - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Blood sodium decreased - Grade 1
|
19.4%
7/36 • Number of events 8
|
|
Investigations
Blood sodium increased - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Investigations
Haemoglobin - Grade 1
|
72.2%
26/36 • Number of events 57
|
|
Investigations
Haemoglobin - Grade 2
|
33.3%
12/36 • Number of events 32
|
|
Investigations
Haemoglobin - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Haemoglobin decreased - Grade 1
|
19.4%
7/36 • Number of events 8
|
|
Investigations
Haemoglobin decreased - Grade 2
|
11.1%
4/36 • Number of events 4
|
|
Investigations
Lymphocyte count decreased - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Lymphocyte count decreased - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Investigations
Platelet count - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Platelet count decreased - Grade 1
|
72.2%
26/36 • Number of events 52
|
|
Investigations
Platelet count decreased - Grade 2
|
13.9%
5/36 • Number of events 8
|
|
Investigations
Transaminases increased - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Troponin I - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Investigations
Weight decreased - Grade 1
|
19.4%
7/36 • Number of events 8
|
|
Investigations
Weight decreased - Grade 2
|
33.3%
12/36 • Number of events 13
|
|
Investigations
Weight decreased - Grade 3
|
8.3%
3/36 • Number of events 4
|
|
Investigations
White blood cell count decreased - Grade 1
|
19.4%
7/36 • Number of events 9
|
|
Investigations
White blood cell count decreased - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
36.1%
13/36 • Number of events 18
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
27.8%
10/36 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia - Grade 3
|
8.3%
3/36 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration - Grade 2
|
16.7%
6/36 • Number of events 6
|
|
Metabolism and nutrition disorders
Gout - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 1
|
52.8%
19/36 • Number of events 34
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 2
|
30.6%
11/36 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 1
|
16.7%
6/36 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypermagnesaemia - Grade 1
|
27.8%
10/36 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypermagnesaemia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesaemia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 1
|
22.2%
8/36 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 2
|
5.6%
2/36 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypernatraemia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 1
|
36.1%
13/36 • Number of events 29
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 2
|
58.3%
21/36 • Number of events 33
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 3
|
8.3%
3/36 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 1
|
30.6%
11/36 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 2
|
25.0%
9/36 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia - Grade 1
|
16.7%
6/36 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoglycaemia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 1
|
25.0%
9/36 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia - Grade 1
|
11.1%
4/36 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesaemia - Grade 2
|
16.7%
6/36 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 1
|
55.6%
20/36 • Number of events 56
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
13.9%
5/36 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis - Grade 1
|
5.6%
2/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness - Grade 1
|
5.6%
2/36 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Dizziness - Grade 1
|
30.6%
11/36 • Number of events 19
|
|
Nervous system disorders
Dysaesthesia - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
19.4%
7/36 • Number of events 13
|
|
Nervous system disorders
Dysgeusia - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Nervous system disorders
Headache - Grade 1
|
13.9%
5/36 • Number of events 5
|
|
Nervous system disorders
Hyperaesthesia - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia - Grade 1
|
13.9%
5/36 • Number of events 5
|
|
Nervous system disorders
Neuroleptic malignant syndrome - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Neuropathy - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Paraesthesia - Grade 1
|
16.7%
6/36 • Number of events 6
|
|
Nervous system disorders
Paraesthesia - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Paraesthesia - Grade 3
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy - Grade 1
|
63.9%
23/36 • Number of events 64
|
|
Nervous system disorders
Peripheral sensory neuropathy - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Peroneal nerve palsy - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Restless legs syndrome - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Nervous system disorders
Tremor - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Vocal cord paralysis - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Psychiatric disorders
Anxiety - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Psychiatric disorders
Anxiety disorder - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Psychiatric disorders
Confusional state - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Psychiatric disorders
Depression - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
Drug dependence - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Psychiatric disorders
Insomnia - Grade 1
|
25.0%
9/36 • Number of events 10
|
|
Psychiatric disorders
Insomnia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Chromaturia - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Dysuria - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
50.0%
18/36 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 3
|
2.8%
1/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia - Grade 1
|
19.4%
7/36 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 1
|
33.3%
12/36 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional - Grade 1
|
11.1%
4/36 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 1
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis - Grade 1
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Drug eruption - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 1
|
16.7%
6/36 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
11.1%
4/36 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
22.2%
8/36 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash generalised - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation - Grade 1
|
2.8%
1/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin lesion - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis - Grade 3
|
8.3%
3/36 • Number of events 3
|
|
Vascular disorders
Flushing - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Hypertension - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Hypertension - Grade 3
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 2
|
5.6%
2/36 • Number of events 2
|
|
Vascular disorders
Lymphorrhoea - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 1
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension - Grade 2
|
2.8%
1/36 • Number of events 1
|
|
Vascular disorders
Phlebitis - Grade 2
|
5.6%
2/36 • Number of events 2
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place