Trial Outcomes & Findings for Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer (NCT NCT01178944)
NCT ID: NCT01178944
Last Updated: 2017-12-13
Results Overview
Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All Cohort -1 treated and eligible patients
Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=31 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Overall Response Rate
|
26 percentage of participants
Interval 12.0 to 45.0
|
SECONDARY outcome
Timeframe: Up to 30 days after the last dose of study drug(s)Population: All treated and eligible patients
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Number of Participants With an Adverse Event
|
35 participants
|
SECONDARY outcome
Timeframe: From the date of study enrollment to the time of death from any cause, assessed up to 5 yearsPopulation: All treated and eligible patients.
Estimated using the Kaplan-Meier method and proportional hazards models.
Outcome measures
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Overall Survival (OS)
|
7.2 months
Interval 6.4 to 10.8
|
SECONDARY outcome
Timeframe: From the date of study enrollment to the first observation of progressive disease, assessed up to 5 yearsPopulation: All treated and eligible patients
Estimated using the Kaplan-Meier method and proportional hazards models.
Outcome measures
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Time to Progression (TTP)
|
5.1 months
Interval 3.4 to 6.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of study enrollment up to 5 yearsPopulation: All treated and eligible patients
Kaplan-Meier estimates of median survival time for each genotype
Outcome measures
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes
C
|
10.22 months
Interval 6.74 to 12.39
|
|
Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes
T
|
18.71 months
Interval 2.33 to 31.38
|
|
Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes
TC
|
4.63 months
Interval 2.3 to 5.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: All treated participants that had enough tissue to perform microdissection to collect epithelial cells for subsequent microRNA profiling.
Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.
Outcome measures
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=29 Participants
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
MicroRNA Expression - miR-215-5p
Responders: CR+PR
|
6.6 Arbitrary fluorescent intensity
Interval 5.7 to 7.1
|
|
MicroRNA Expression - miR-215-5p
Non responders: stable disease/progression
|
5.6 Arbitrary fluorescent intensity
Interval 5.3 to 5.9
|
Adverse Events
Treatment (Pralatrexate, Oxaliplatin)
Serious events: 10 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 participants at risk
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Disease progression
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Pyrexia
|
2.9%
1/35 • Number of events 2
|
|
Infections and infestations
Infection
|
2.9%
1/35 • Number of events 4
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 2
|
|
Investigations
Haemoglobin
|
2.9%
1/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
3/35 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
1/35 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
2.9%
1/35 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
2.9%
1/35 • Number of events 2
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Pralatrexate, Oxaliplatin)
n=35 participants at risk
Patients receive pralatrexate IV over 3-5 minutes and oxaliplatin IV over 2 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Oxaliplatin will be discontinued after 12 courses.
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Pralatrexate: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.7%
9/35 • Number of events 37
|
|
Blood and lymphatic system disorders
Leukopenia
|
34.3%
12/35 • Number of events 65
|
|
Blood and lymphatic system disorders
Lymphopenia
|
34.3%
12/35 • Number of events 32
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.3%
12/35 • Number of events 42
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
10/35 • Number of events 50
|
|
Cardiac disorders
Tachycardia
|
8.6%
3/35 • Number of events 6
|
|
Eye disorders
Dry eye
|
2.9%
1/35 • Number of events 4
|
|
Eye disorders
Eye discharge
|
5.7%
2/35 • Number of events 4
|
|
Eye disorders
Eye pain
|
2.9%
1/35 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
2.9%
1/35 • Number of events 2
|
|
Eye disorders
Vision blurred
|
5.7%
2/35 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
7/35 • Number of events 16
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.6%
3/35 • Number of events 6
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
37.1%
13/35 • Number of events 42
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
14/35 • Number of events 71
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
17.1%
6/35 • Number of events 20
|
|
Gastrointestinal disorders
Faecal incontinence
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
62.9%
22/35 • Number of events 96
|
|
Gastrointestinal disorders
Odynophagia
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Oesophagitis
|
2.9%
1/35 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
85.7%
30/35 • Number of events 169
|
|
Gastrointestinal disorders
Vomiting
|
48.6%
17/35 • Number of events 55
|
|
General disorders
Asthenia
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Chest pain
|
11.4%
4/35 • Number of events 8
|
|
General disorders
Chills
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Early satiety
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Fatigue
|
65.7%
23/35 • Number of events 103
|
|
General disorders
Gait disturbance
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Infusion site extravasation
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Localised oedema
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Oedema
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Oedema peripheral
|
22.9%
8/35 • Number of events 25
|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 2
|
|
General disorders
Pyrexia
|
8.6%
3/35 • Number of events 6
|
|
General disorders
Temperature intolerance
|
8.6%
3/35 • Number of events 10
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.7%
2/35 • Number of events 8
|
|
Immune system disorders
Hypersensitivity
|
8.6%
3/35 • Number of events 6
|
|
Infections and infestations
Abdominal wall infection
|
2.9%
1/35 • Number of events 2
|
|
Infections and infestations
Infection
|
2.9%
1/35 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/35 • Number of events 2
|
|
Infections and infestations
Oral candidiasis
|
5.7%
2/35 • Number of events 4
|
|
Infections and infestations
Oral infection
|
2.9%
1/35 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • Number of events 2
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
1/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
2.9%
1/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.9%
1/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.9%
1/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.9%
1/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.9%
1/35 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
2/35 • Number of events 10
|
|
Investigations
Aspartate aminotransferase
|
14.3%
5/35 • Number of events 16
|
|
Investigations
Aspartate aminotransferase increased
|
34.3%
12/35 • Number of events 40
|
|
Investigations
Blood alkaline phosphatase
|
17.1%
6/35 • Number of events 15
|
|
Investigations
Blood alkaline phosphatase increased
|
25.7%
9/35 • Number of events 27
|
|
Investigations
Blood creatinine
|
11.4%
4/35 • Number of events 10
|
|
Investigations
Blood creatinine increased
|
5.7%
2/35 • Number of events 3
|
|
Investigations
Carbon dioxide increased
|
2.9%
1/35 • Number of events 2
|
|
Investigations
Haemoglobin
|
34.3%
12/35 • Number of events 75
|
|
Investigations
Haemoglobin decreased
|
25.7%
9/35 • Number of events 47
|
|
Investigations
Lymphocyte count decreased
|
25.7%
9/35 • Number of events 49
|
|
Investigations
Neutrophil count decreased
|
14.3%
5/35 • Number of events 13
|
|
Investigations
Platelet count decreased
|
14.3%
5/35 • Number of events 21
|
|
Investigations
Weight decreased
|
40.0%
14/35 • Number of events 42
|
|
Investigations
White blood cell count decreased
|
17.1%
6/35 • Number of events 18
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.7%
9/35 • Number of events 25
|
|
Metabolism and nutrition disorders
Dehydration
|
22.9%
8/35 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.7%
2/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
7/35 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
11.4%
4/35 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
51.4%
18/35 • Number of events 69
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.6%
3/35 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
1/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
4/35 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
1/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
22.9%
8/35 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/35 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
5/35 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.9%
1/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
5/35 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
1/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
2/35 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
4/35 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.9%
1/35 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
17.1%
6/35 • Number of events 16
|
|
Nervous system disorders
Dizziness postural
|
2.9%
1/35 • Number of events 2
|
|
Nervous system disorders
Dysaesthesia
|
5.7%
2/35 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
31.4%
11/35 • Number of events 24
|
|
Nervous system disorders
Headache
|
17.1%
6/35 • Number of events 11
|
|
Nervous system disorders
Neuropathy peripheral
|
2.9%
1/35 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
11.4%
4/35 • Number of events 22
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
77.1%
27/35 • Number of events 106
|
|
Nervous system disorders
Peroneal nerve palsy
|
2.9%
1/35 • Number of events 4
|
|
Nervous system disorders
Sinus headache
|
2.9%
1/35 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
5.7%
2/35 • Number of events 6
|
|
Psychiatric disorders
Confusional state
|
2.9%
1/35 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
2.9%
1/35 • Number of events 2
|
|
Psychiatric disorders
Hallucination
|
2.9%
1/35 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/35 • Number of events 4
|
|
Psychiatric disorders
Restlessness
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
Chromaturia
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.9%
1/35 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
5.7%
2/35 • Number of events 3
|
|
Renal and urinary disorders
Urinary incontinence
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
5/35 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.4%
4/35 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
34.3%
12/35 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.6%
3/35 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.7%
2/35 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/35 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.7%
2/35 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
2/35 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.9%
1/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
2/35 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.9%
1/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.1%
6/35 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.9%
1/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.9%
1/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.9%
1/35 • Number of events 2
|
|
Surgical and medical procedures
Medical diet
|
2.9%
1/35 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
5/35 • Number of events 10
|
|
Vascular disorders
Embolism
|
2.9%
1/35 • Number of events 2
|
|
Vascular disorders
Hot flush
|
2.9%
1/35 • Number of events 2
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Number of events 2
|
|
Vascular disorders
Hypotension
|
14.3%
5/35 • Number of events 10
|
|
Vascular disorders
Orthostatic hypotension
|
2.9%
1/35 • Number of events 2
|
|
Vascular disorders
Superior vena cava syndrome
|
2.9%
1/35 • 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