Trial Outcomes & Findings for Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction (NCT NCT00757172)
NCT ID: NCT00757172
Last Updated: 2016-03-11
Results Overview
Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Post surgery
Results posted on
2016-03-11
Participant Flow
Seventy participants were recruited between January 2009 to July 2011 from 24 institutions.
Five participants were declared ineligible. One participant had a celiac lymph node \>2 cm and one participant had two primary tumors. Liver lesions were noted and not investigated in one participant. Two participants had Siewert type III tumors. These five participants were excluded from all analysis except adverse events.
Participant milestones
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Progression
|
4
|
Baseline Characteristics
Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction
Baseline characteristics by cohort
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=65 Participants
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0= Asymptomatic and fully active
|
37 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1= Symptomatic; fully ambulatory
|
28 participants
n=99 Participants
|
|
Body Mass Index (BMI)
|
27.8 kg/m^2
n=99 Participants
|
|
Tumor location (Siewert Type)
I
|
36 participants
n=99 Participants
|
|
Tumor location (Siewert Type)
II
|
29 participants
n=99 Participants
|
|
Clinical T Stage
T2 = Tumor invades muscularis propria
|
7 participants
n=99 Participants
|
|
Clinical T Stage
T3= Tumor invades adventitia
|
58 participants
n=99 Participants
|
|
Clinical N Stage
N0= No regional lymph node metastasis
|
13 participants
n=99 Participants
|
|
Clinical N Stage
N1= Regional lymph node metastasis
|
52 participants
n=99 Participants
|
|
Clinical M Stage
M0= No distant metastasis
|
56 participants
n=99 Participants
|
|
Clinical M Stage
M1a= Metastasis in celiac or cervical lymph nodes
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Post surgeryPopulation: All participants who have met the eligibility criteria that have signed a consent form and began treatment.
Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Outcome measures
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=54 Participants
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Number of Participants With Pathologic Complete Response Following Surgery
|
18 participants
|
SECONDARY outcome
Timeframe: Post surgeryPopulation: All participants who have met the eligibility criteria that have signed a consent form and began treatment.
Outcome measures
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=54 Participants
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)
|
11 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All registered participants who have met the eligibility criteria.
Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).
Outcome measures
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=65 Participants
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Percentage of Participants With 3-year Overall Survival
|
38.6 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All registered participants who have met the eligibility criteria.
Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.
Outcome measures
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=65 Participants
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Percentage of Participants With 2-year Disease-free Survival
|
41.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgeryPopulation: All recruited participants.
Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.
Outcome measures
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=70 Participants
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Hemoglobin
|
12 participants
|
|
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Lymphocytes
|
30 participants
|
|
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Neutrophils
|
12 participants
|
|
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Dehydration
|
13 participants
|
|
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Esophagitis
|
13 participants
|
|
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Nausea
|
11 participants
|
Adverse Events
Docetaxel + Cisplatin + Panitumumab + RT
Serious events: 46 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=70 participants at risk
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
3/70 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
15.7%
11/70 • Number of events 12
|
|
Cardiac disorders
Atrial fibrillation
|
5.7%
4/70 • Number of events 5
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/70 • Number of events 3
|
|
Gastrointestinal disorders
Anal pain
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
4/70 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
4/70 • Number of events 4
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Esophageal fistula
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal perforation
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal ulcer
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
7/70 • Number of events 8
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Malabsorption
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
14.3%
10/70 • Number of events 11
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
9/70 • Number of events 9
|
|
General disorders
Edema limbs
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Fatigue
|
2.9%
2/70 • Number of events 3
|
|
General disorders
General symptom
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Multi-organ failure
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Device related infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Endocarditis infective
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Infection
|
7.1%
5/70 • Number of events 5
|
|
Infections and infestations
Pleural infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.3%
3/70 • Number of events 3
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
2/70 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • Number of events 2
|
|
Infections and infestations
Wound infection
|
4.3%
3/70 • Number of events 3
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
2.9%
2/70 • Number of events 2
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Esophagus
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
3/70 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
2/70 • Number of events 2
|
|
Investigations
Bilirubin increased
|
2.9%
2/70 • Number of events 2
|
|
Investigations
Cardiac troponin I increased
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Creatinine increased
|
1.4%
1/70 • Number of events 1
|
|
Investigations
INR increased
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
1.4%
1/70 • Number of events 3
|
|
Investigations
Leukocyte count decreased
|
11.4%
8/70 • Number of events 9
|
|
Investigations
Lymphocyte count decreased
|
21.4%
15/70 • Number of events 18
|
|
Investigations
Neutrophil count decreased
|
8.6%
6/70 • Number of events 7
|
|
Investigations
Platelet count decreased
|
2.9%
2/70 • Number of events 2
|
|
Investigations
Weight loss
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
2.9%
2/70 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.9%
2/70 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
3/70 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
4.3%
3/70 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
10/70 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
12.9%
9/70 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
7.1%
5/70 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.9%
2/70 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
5.7%
4/70 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.7%
4/70 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.3%
3/70 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.9%
2/70 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.9%
2/70 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.4%
1/70 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.9%
2/70 • Number of events 2
|
|
Renal and urinary disorders
Urogenital disorder
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.9%
2/70 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
2.9%
2/70 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.6%
6/70 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
3/70 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
5/70 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
2/70 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.3%
3/70 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.9%
2/70 • Number of events 2
|
|
Vascular disorders
Hematoma
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.3%
3/70 • Number of events 3
|
|
Vascular disorders
Thrombosis
|
14.3%
10/70 • Number of events 13
|
|
Vascular disorders
Visceral arterial ischemia
|
1.4%
1/70 • Number of events 1
|
Other adverse events
| Measure |
Docetaxel + Cisplatin + Panitumumab + RT
n=70 participants at risk
Patients received docetaxel (40 mg/m\^2), cisplatin (40 mg/m\^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
3/70 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
55.7%
39/70 • Number of events 139
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.7%
4/70 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
11.4%
8/70 • Number of events 8
|
|
Cardiac disorders
Atrial tachycardia
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Cardiac disorder
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Conduction disorder
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Premature ventricular contractions
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing loss
|
4.3%
3/70 • Number of events 12
|
|
Eye disorders
Diplopia
|
1.4%
1/70 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
1.4%
1/70 • Number of events 1
|
|
Eye disorders
Eye disorder
|
1.4%
1/70 • Number of events 2
|
|
Eye disorders
Eyelid function disorder
|
1.4%
1/70 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.9%
2/70 • Number of events 2
|
|
Eye disorders
Watering eyes
|
2.9%
2/70 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
2/70 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
8/70 • Number of events 14
|
|
Gastrointestinal disorders
Anal exam abnormal
|
2.9%
2/70 • Number of events 5
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
25.7%
18/70 • Number of events 32
|
|
Gastrointestinal disorders
Diarrhea
|
52.9%
37/70 • Number of events 76
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
17.1%
12/70 • Number of events 27
|
|
Gastrointestinal disorders
Dysphagia
|
42.9%
30/70 • Number of events 49
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
18.6%
13/70 • Number of events 22
|
|
Gastrointestinal disorders
Esophageal pain
|
5.7%
4/70 • Number of events 7
|
|
Gastrointestinal disorders
Esophagitis
|
51.4%
36/70 • Number of events 77
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
14.3%
10/70 • Number of events 18
|
|
Gastrointestinal disorders
Gingival pain
|
2.9%
2/70 • Number of events 4
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
11.4%
8/70 • Number of events 11
|
|
Gastrointestinal disorders
Nausea
|
70.0%
49/70 • Number of events 125
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
1.4%
1/70 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
28/70 • Number of events 44
|
|
General disorders
Chest pain
|
4.3%
3/70 • Number of events 3
|
|
General disorders
Chills
|
10.0%
7/70 • Number of events 10
|
|
General disorders
Edema limbs
|
5.7%
4/70 • Number of events 6
|
|
General disorders
Fatigue
|
71.4%
50/70 • Number of events 162
|
|
General disorders
Fever
|
10.0%
7/70 • Number of events 10
|
|
General disorders
General symptom
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Injection site reaction
|
2.9%
2/70 • Number of events 2
|
|
General disorders
Localized edema
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Pain
|
15.7%
11/70 • Number of events 22
|
|
Immune system disorders
Cytokine release syndrome
|
1.4%
1/70 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
18.6%
13/70 • Number of events 16
|
|
Infections and infestations
Bronchitis
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Eye infection
|
2.9%
2/70 • Number of events 2
|
|
Infections and infestations
Infection
|
7.1%
5/70 • Number of events 7
|
|
Infections and infestations
Opportunistic infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Paranasal sinus infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Pleural infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Sepsis
|
4.3%
3/70 • Number of events 3
|
|
Infections and infestations
Skin infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
1/70 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Wound infection
|
5.7%
4/70 • Number of events 4
|
|
Injury, poisoning and procedural complications
Bruising
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
12.9%
9/70 • Number of events 14
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.4%
1/70 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
24.3%
17/70 • Number of events 24
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
10/70 • Number of events 20
|
|
Investigations
Aspartate aminotransferase increased
|
27.1%
19/70 • Number of events 25
|
|
Investigations
Bilirubin increased
|
11.4%
8/70 • Number of events 12
|
|
Investigations
Creatinine increased
|
21.4%
15/70 • Number of events 21
|
|
Investigations
INR increased
|
2.9%
2/70 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
4.3%
3/70 • Number of events 22
|
|
Investigations
Leukocyte count decreased
|
80.0%
56/70 • Number of events 156
|
|
Investigations
Lymphocyte count decreased
|
41.4%
29/70 • Number of events 79
|
|
Investigations
Neutrophil count decreased
|
25.7%
18/70 • Number of events 30
|
|
Investigations
Platelet count decreased
|
57.1%
40/70 • Number of events 91
|
|
Investigations
Weight gain
|
1.4%
1/70 • Number of events 1
|
|
Investigations
Weight loss
|
27.1%
19/70 • Number of events 30
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
30/70 • Number of events 67
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
2.9%
2/70 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
42.9%
30/70 • Number of events 73
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
20/70 • Number of events 29
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
40.0%
28/70 • Number of events 85
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
32.9%
23/70 • Number of events 49
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.9%
2/70 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
51.4%
36/70 • Number of events 90
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
11.4%
8/70 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
12.9%
9/70 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
25.7%
18/70 • Number of events 31
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
14.3%
10/70 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
22.9%
16/70 • Number of events 35
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
10.0%
7/70 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/70 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
5/70 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
4.3%
3/70 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.6%
6/70 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.3%
17/70 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
22.9%
16/70 • Number of events 28
|
|
Nervous system disorders
Headache
|
4.3%
3/70 • Number of events 4
|
|
Nervous system disorders
Neurological disorder NOS
|
4.3%
3/70 • Number of events 4
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
31.4%
22/70 • Number of events 56
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Seizure
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
18.6%
13/70 • Number of events 36
|
|
Nervous system disorders
Tremor
|
2.9%
2/70 • Number of events 3
|
|
Psychiatric disorders
Agitation
|
2.9%
2/70 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
14.3%
10/70 • Number of events 37
|
|
Psychiatric disorders
Confusion
|
2.9%
2/70 • Number of events 2
|
|
Psychiatric disorders
Depression
|
4.3%
3/70 • Number of events 8
|
|
Psychiatric disorders
Insomnia
|
15.7%
11/70 • Number of events 38
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Protein urine positive
|
5.7%
4/70 • Number of events 4
|
|
Renal and urinary disorders
Urinary frequency
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
4.3%
3/70 • Number of events 3
|
|
Reproductive system and breast disorders
Penile pain
|
1.4%
1/70 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.4%
1/70 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
1.4%
1/70 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.7%
4/70 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
20/70 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.9%
16/70 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/70 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
8.6%
6/70 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.3%
3/70 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
24.3%
17/70 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.3%
3/70 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.7%
4/70 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.7%
4/70 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.7%
4/70 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.1%
19/70 • Number of events 49
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
8/70 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
47.1%
33/70 • Number of events 82
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
94.3%
66/70 • Number of events 279
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
37.1%
26/70 • Number of events 60
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.9%
2/70 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Flushing
|
2.9%
2/70 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
1.4%
1/70 • Number of events 3
|
|
Vascular disorders
Hypertension
|
4.3%
3/70 • Number of events 3
|
|
Vascular disorders
Hypotension
|
15.7%
11/70 • Number of events 15
|
|
Vascular disorders
Phlebitis
|
2.9%
2/70 • Number of events 3
|
|
Vascular disorders
Thrombosis
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Vascular disorder
|
1.4%
1/70 • Number of events 1
|
Additional Information
Dr. A. Craig Lockhart
Washington University School of Medicine
Phone: 314-454-8306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place