Trial Outcomes & Findings for S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00368992)
NCT ID: NCT00368992
Last Updated: 2015-09-14
Results Overview
All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Every week until removed from protocol therapy, up to 3 years.
Results posted on
2015-09-14
Participant Flow
Participant milestones
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
110
|
Reasons for withdrawal
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Ineligible
|
5
|
|
Overall Study
Refused treatment
|
3
|
|
Overall Study
Lack of Efficacy
|
63
|
|
Overall Study
Adverse Event
|
26
|
|
Overall Study
Death
|
4
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=102 Participants
This was a single arm Phase II trial. Patients were treated until progression.
|
|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Every week until removed from protocol therapy, up to 3 years.Population: Eligible patients who received protocol treatment were included in the analysis.
All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.
Outcome measures
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=102 Participants
|
|---|---|
|
The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.
|
2 percentage of participants
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.Population: Eligible patients who received protocol treatment were included in the analysis.
From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.
Outcome measures
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=102 Participants
|
|---|---|
|
Progression-Free Survival
|
7 Months
Interval 6.0 to 8.0
|
SECONDARY outcome
Timeframe: Once a week, up to 3 years.Population: Eligible patients who received protocol treatment were included in the analysis.
From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.
Outcome measures
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=102 Participants
|
|---|---|
|
Overall Survival
|
15 months
Interval 11.0 to 21.0
|
SECONDARY outcome
Timeframe: Every 6 weeks while on protocol treatment, up to 3 years.Population: Eligible patients who received protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.
Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a \>= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.
Outcome measures
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=95 Participants
|
|---|---|
|
Response Rate
|
56 percentage of participants
Interval 44.0 to 65.0
|
Adverse Events
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
Serious events: 51 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=102 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.9%
5/102 • Weekly while on protocol treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Eye disorders
Ocular/Visual-Other (Specify)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
5/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
General disorders
Sudden death
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
3.9%
4/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Joint
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
2.9%
3/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Investigations
Leukocytes (total WBC)
|
2.9%
3/102 • Weekly while on protocol treatment.
|
|
Investigations
Lymphopenia
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
15.7%
16/102 • Weekly while on protocol treatment.
|
|
Investigations
Platelets
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
3/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
7/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
2.9%
3/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other (Specify)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Buttock
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
2.9%
3/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Neuropathy: motor
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Ocular/Visual-Other (Specify)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Seizure
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Syncope (fainting)
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Reproductive system and breast disorders
Vaginitis (not due to infection)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.8%
9/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
3/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pleura
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.9%
4/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Vascular disorders
Hypertension
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Vascular disorders
Hypotension
|
2.0%
2/102 • Weekly while on protocol treatment.
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.98%
1/102 • Weekly while on protocol treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.9%
7/102 • Weekly while on protocol treatment.
|
Other adverse events
| Measure |
Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab
n=102 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
56.9%
58/102 • Weekly while on protocol treatment.
|
|
Eye disorders
Vision-blurred vision
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
55.9%
57/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
44.1%
45/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
6.9%
7/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
14.7%
15/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
35.3%
36/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
20.6%
21/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
52.0%
53/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
10.8%
11/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
25/102 • Weekly while on protocol treatment.
|
|
General disorders
Edema: limb
|
9.8%
10/102 • Weekly while on protocol treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
86.3%
88/102 • Weekly while on protocol treatment.
|
|
General disorders
Pain - Chest/thorax NOS
|
9.8%
10/102 • Weekly while on protocol treatment.
|
|
General disorders
Pain-Other (Specify)
|
13.7%
14/102 • Weekly while on protocol treatment.
|
|
General disorders
Rigors/chills
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
13.7%
14/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
10.8%
11/102 • Weekly while on protocol treatment.
|
|
Infections and infestations
Infection-Other (Specify)
|
7.8%
8/102 • Weekly while on protocol treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
21.6%
22/102 • Weekly while on protocol treatment.
|
|
Investigations
AST, SGOT
|
21.6%
22/102 • Weekly while on protocol treatment.
|
|
Investigations
Alkaline phosphatase
|
30.4%
31/102 • Weekly while on protocol treatment.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
7.8%
8/102 • Weekly while on protocol treatment.
|
|
Investigations
Creatinine
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
Investigations
Leukocytes (total WBC)
|
51.0%
52/102 • Weekly while on protocol treatment.
|
|
Investigations
Lymphopenia
|
8.8%
9/102 • Weekly while on protocol treatment.
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
60.8%
62/102 • Weekly while on protocol treatment.
|
|
Investigations
Platelets
|
39.2%
40/102 • Weekly while on protocol treatment.
|
|
Investigations
Weight loss
|
39.2%
40/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
29.4%
30/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.2%
43/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
30.4%
31/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
17/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
54.9%
56/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
10.8%
11/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
49.0%
50/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
10.8%
11/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
20.6%
21/102 • Weekly while on protocol treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
28.4%
29/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
7.8%
8/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
13.7%
14/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
18.6%
19/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
16.7%
17/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
8.8%
9/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
19.6%
20/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
31.4%
32/102 • Weekly while on protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
23.5%
24/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Dizziness
|
20.6%
21/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Neuropathy: motor
|
10.8%
11/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
74.5%
76/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Pain - Head/headache
|
12.7%
13/102 • Weekly while on protocol treatment.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
24.5%
25/102 • Weekly while on protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
18.6%
19/102 • Weekly while on protocol treatment.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
14.7%
15/102 • Weekly while on protocol treatment.
|
|
Psychiatric disorders
Mood alteration - depression
|
18.6%
19/102 • Weekly while on protocol treatment.
|
|
Renal and urinary disorders
Proteinuria
|
12.7%
13/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.8%
10/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.5%
27/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
43.1%
44/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
26.5%
27/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (functional/symp) - Pharynx
|
6.9%
7/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
7.8%
8/102 • Weekly while on protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
20.6%
21/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
15.7%
16/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.5%
26/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
49.0%
50/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.9%
6/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
21.6%
22/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
30.4%
31/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
76.5%
78/102 • Weekly while on protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
8.8%
9/102 • Weekly while on protocol treatment.
|
|
Vascular disorders
Hypertension
|
24.5%
25/102 • Weekly while on protocol treatment.
|
|
Vascular disorders
Hypotension
|
11.8%
12/102 • Weekly while on protocol treatment.
|
Additional Information
Lung Committee Statistician
SWOG
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60