Trial Outcomes & Findings for Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery (NCT NCT00589056)
NCT ID: NCT00589056
Last Updated: 2020-04-24
Results Overview
Any grade III or higher toxicity during chemoradiation, per CTCAE
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
90 days
Results posted on
2020-04-24
Participant Flow
Participant milestones
| Measure |
Single Arm
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nelfinavir, Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Single Arm
n=55 Participants
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysAny grade III or higher toxicity during chemoradiation, per CTCAE
Outcome measures
| Measure |
Single Arm
n=55 Participants
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Dose-limiting Toxicity
|
0 Dose-limiting toxicities
|
PRIMARY outcome
Timeframe: 90 daysAs determined by dose escalation rules
Outcome measures
| Measure |
Single Arm
n=55 Participants
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Maximum Tolerated Dose of Nelfinavir
|
1250 mg PO twice daily
|
SECONDARY outcome
Timeframe: 90 daysTumor size as determined by imaging
Outcome measures
| Measure |
Single Arm
n=55 Participants
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Clinical Response of Tumor
|
94 percentage of participants
Interval 86.0 to 100.0
|
Adverse Events
Single Arm
Serious events: 21 serious events
Other events: 40 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Single Arm
n=55 participants at risk
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Blood and lymphatic system disorders
ANC
|
5.5%
3/55 • Number of events 4
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
5.5%
3/55 • Number of events 3
|
|
Blood and lymphatic system disorders
Decreased ANC
|
3.6%
2/55 • Number of events 3
|
|
Gastrointestinal disorders
Dehydration
|
5.5%
3/55 • Number of events 3
|
|
General disorders
Diffuse Muscle Pain
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
3.6%
2/55 • Number of events 3
|
|
General disorders
Fatigue
|
3.6%
2/55 • Number of events 2
|
|
Infections and infestations
Febrile neutropenia
|
5.5%
3/55 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.8%
1/55 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infection, Anal/perianal
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infection, Lung (pneumonia)
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes
|
16.4%
9/55 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Neutropenic Fever
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
3.6%
2/55 • Number of events 4
|
|
General disorders
Pain in extremity
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.5%
3/55 • Number of events 3
|
|
Nervous system disorders
Syncope
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.6%
2/55 • Number of events 2
|
Other adverse events
| Measure |
Single Arm
n=55 participants at risk
Nelfinavir
cisplatin
etoposide
nelfinavir mesylate
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
radiation therapy
|
|---|---|
|
Blood and lymphatic system disorders
ANC
|
7.3%
4/55 • Number of events 12
|
|
Blood and lymphatic system disorders
AST Transaminase
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Abdominal Pain
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
1.8%
1/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
7.3%
4/55 • Number of events 4
|
|
Metabolism and nutrition disorders
Alkalosis
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
5/55 • Number of events 5
|
|
General disorders
Altered Taste
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
43.6%
24/55 • Number of events 41
|
|
Psychiatric disorders
Anxiety
|
14.5%
8/55 • Number of events 10
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
3/55 • Number of events 4
|
|
Gastrointestinal disorders
Bloating
|
1.8%
1/55 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
3.6%
2/55 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Cellulitis at hangnail
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest Congestion
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
20.0%
11/55 • Number of events 11
|
|
General disorders
Chills
|
3.6%
2/55 • Number of events 2
|
|
Metabolism and nutrition disorders
Cholesterol
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Confusion / Forgetfulness
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
47.3%
26/55 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.9%
17/55 • Number of events 28
|
|
Metabolism and nutrition disorders
Cramping
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
5.5%
3/55 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea on exertion
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Decreased ALC
|
1.8%
1/55 • Number of events 5
|
|
Blood and lymphatic system disorders
Decreased ANC
|
18.2%
10/55 • Number of events 17
|
|
General disorders
Decreased Albumin
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased Leukocytes
|
7.3%
4/55 • Number of events 11
|
|
General disorders
Decreased Magnesium
|
3.6%
2/55 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased Platelets
|
7.3%
4/55 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased WBC
|
7.3%
4/55 • Number of events 5
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
9.1%
5/55 • Number of events 11
|
|
Blood and lymphatic system disorders
Decreased leukocytes
|
10.9%
6/55 • Number of events 13
|
|
Blood and lymphatic system disorders
Decreased platelets
|
5.5%
3/55 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
40.0%
22/55 • Number of events 34
|
|
Psychiatric disorders
Depression
|
16.4%
9/55 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.9%
6/55 • Number of events 7
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
14.5%
8/55 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Desquamation
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Diaphoresis
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
43.6%
24/55 • Number of events 45
|
|
General disorders
Difficulty Swallowing
|
3.6%
2/55 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
21.8%
12/55 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
2/55 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Dysgeusia
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
29.1%
16/55 • Number of events 29
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
22/55 • Number of events 38
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.9%
17/55 • Number of events 23
|
|
Renal and urinary disorders
Dysuria
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Esophagitis
|
1.8%
1/55 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Pain
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Edema
|
10.9%
6/55 • Number of events 6
|
|
General disorders
Epigastrum
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
5/55 • Number of events 5
|
|
General disorders
Esophageal Pain
|
14.5%
8/55 • Number of events 10
|
|
Gastrointestinal disorders
Esophagitis
|
61.8%
34/55 • Number of events 63
|
|
General disorders
Facial Erythema
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Fatigue
|
60.0%
33/55 • Number of events 71
|
|
General disorders
Feet Tingling
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Fever
|
10.9%
6/55 • Number of events 8
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Flushing
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Other GI
|
5.5%
3/55 • Number of events 3
|
|
General disorders
Giddiness
|
1.8%
1/55 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand Laceration
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Hand Tremors
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Headache
|
16.4%
9/55 • Number of events 10
|
|
Ear and labyrinth disorders
Hearing Loss
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Heart palpitations / A-fib / Chest pains
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
14.5%
8/55 • Number of events 9
|
|
General disorders
Heavy chest
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematuria
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
45.5%
25/55 • Number of events 70
|
|
Blood and lymphatic system disorders
Hemoptysis
|
7.3%
4/55 • Number of events 5
|
|
Injury, poisoning and procedural complications
Hemorrhage
|
5.5%
3/55 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
5.5%
3/55 • Number of events 5
|
|
General disorders
Hiccups
|
3.6%
2/55 • Number of events 3
|
|
General disorders
Hoarseness
|
12.7%
7/55 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
7.3%
4/55 • Number of events 4
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.3%
26/55 • Number of events 80
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
5/55 • Number of events 7
|
|
General disorders
Hyperpigmentation in RT Field
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
47.3%
26/55 • Number of events 66
|
|
General disorders
Hypoantremia
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
47.3%
26/55 • Number of events 57
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
14.5%
8/55 • Number of events 12
|
|
Blood and lymphatic system disorders
Hypokalemia
|
29.1%
16/55 • Number of events 26
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
16.4%
9/55 • Number of events 20
|
|
Blood and lymphatic system disorders
Hyponatremia
|
56.4%
31/55 • Number of events 62
|
|
Cardiac disorders
Hypotension
|
14.5%
8/55 • Number of events 9
|
|
Endocrine disorders
Increased ALT
|
10.9%
6/55 • Number of events 6
|
|
Blood and lymphatic system disorders
Increased Alk Phosphates
|
7.3%
4/55 • Number of events 5
|
|
Blood and lymphatic system disorders
Increased Creatinine
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Increased DOE
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Increased Triglycerides
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infected L Eye
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
16.4%
9/55 • Number of events 9
|
|
Blood and lymphatic system disorders
Intermittent Decreased Magnesium
|
1.8%
1/55 • Number of events 1
|
|
Reproductive system and breast disorders
Irregular Menses
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Jaw Pain
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Joint pain
|
1.8%
1/55 • Number of events 2
|
|
General disorders
L Arm Pain
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
LLE DVT
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Left bundle branch block
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Left side burning sensation
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Leg Cramps
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
43.6%
24/55 • Number of events 72
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
1/55 • Number of events 3
|
|
General disorders
Light headedness
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Loose Stool
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
5/55 • Number of events 16
|
|
Metabolism and nutrition disorders
decreased total protein
|
3.6%
2/55 • Number of events 2
|
|
Psychiatric disorders
Mood Alteration
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Myalgia
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
54.5%
30/55 • Number of events 59
|
|
General disorders
Neck Swelling
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Neuropathy
|
3.6%
2/55 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophils
|
16.4%
9/55 • Number of events 19
|
|
General disorders
Night Sweats
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Nosebleed
|
3.6%
2/55 • Number of events 2
|
|
Gastrointestinal disorders
Odynophagia
|
7.3%
4/55 • Number of events 5
|
|
Infections and infestations
Oral Mucositis
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Orthostatic Hypotension
|
14.5%
8/55 • Number of events 8
|
|
General disorders
Pain
|
14.5%
8/55 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Palmar Rash
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopemia
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.5%
3/55 • Number of events 3
|
|
Injury, poisoning and procedural complications
Pharyngeal hemorrhage
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
21.8%
12/55 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Poor bladder function
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.5%
3/55 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
R Thoracic Pain
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rad Derm
|
3.6%
2/55 • Number of events 3
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
9.1%
5/55 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Radiation recall reaction (dermatologic)
|
1.8%
1/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
8/55 • Number of events 8
|
|
Reproductive system and breast disorders
Rectal Pain 2d Herpes
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Reflux
|
5.5%
3/55 • Number of events 3
|
|
Infections and infestations
Respiratory Infection
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
SOB
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Severe headache
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Rash / Dryness (XRT Derm)
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Sensation - burning
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin in rad portal
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Sleepiness
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Sore R Cheek in Mouth
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Sore Throat
|
7.3%
4/55 • Number of events 4
|
|
Gastrointestinal disorders
Stomach cramping
|
3.6%
2/55 • Number of events 2
|
|
Eye disorders
Stye
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Suprapubic Pain 2d UTI
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Sweating
|
5.5%
3/55 • Number of events 3
|
|
General disorders
Swelling of Ankles
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Systolic Blood Pressure
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Tachycardia - A-fib
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Taste Alteration
|
5.5%
3/55 • Number of events 3
|
|
Gastrointestinal disorders
Throat pain
|
1.8%
1/55 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
5/55 • Number of events 10
|
|
Gastrointestinal disorders
Thrush
|
7.3%
4/55 • Number of events 4
|
|
Ear and labyrinth disorders
Tinnitus
|
14.5%
8/55 • Number of events 9
|
|
Eye disorders
Tunnel Vision
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Upper Abdominal Pain
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Voice Change
|
14.5%
8/55 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
21.8%
12/55 • Number of events 17
|
|
Blood and lymphatic system disorders
WBC Decreased
|
1.8%
1/55 • Number of events 4
|
|
General disorders
Weakness
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Weight Gain
|
3.6%
2/55 • Number of events 2
|
|
General disorders
Weight Loss
|
41.8%
23/55 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
1/55 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
XRT Dermatitis
|
14.5%
8/55 • Number of events 9
|
|
Injury, poisoning and procedural complications
Full extravasation - AC fossa
|
1.8%
1/55 • Number of events 1
|
Additional Information
Ramesh Rengan, M.D., Ph.D.
University of Pennsylvania
Phone: (215) 662-2428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place