Trial Outcomes & Findings for Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers (NCT NCT01344824)
NCT ID: NCT01344824
Last Updated: 2017-10-30
Results Overview
Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: 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. criteria each year, until subject death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
1400 days
Results posted on
2017-10-30
Participant Flow
Patients were recruited from institutions including University of North Carolina Hospitals, University of Pittsburgh Medical Center, Mission Cancer Center, and New Bern Cancer Center.
From March 2010 to November 2013, 52 patients consented to treatment. 14 patients were consented and screened for eligibility but found ineligible.
Participant milestones
| Measure |
Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Bevacizumab, Carboplatin, and Pemetrexed Disodium, With Option
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Other complicating disease
|
1
|
|
Overall Study
Progression
|
15
|
Baseline Characteristics
Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers
Baseline characteristics by cohort
| Measure |
Single Arm Trial
n=38 Participants
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
grade 0
|
18 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
grade 1
|
14 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
not performed
|
6 Participants
n=5 Participants
|
|
Smoking Status
Never smoker
|
24 Participants
n=5 Participants
|
|
Smoking Status
Former light smoker
|
14 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
37 Participants
n=5 Participants
|
|
Histology
Neuroendocrine carcinoma
|
1 Participants
n=5 Participants
|
|
Previous erlotinib treatment
|
10 Participants
n=5 Participants
|
|
Mutation status
EGFR
|
6 Participants
n=5 Participants
|
|
Mutation status
KRAS
|
5 Participants
n=5 Participants
|
|
Mutation status
EML4/ALK
|
0 Participants
n=5 Participants
|
|
Mutation status
MET del14
|
1 Participants
n=5 Participants
|
|
Mutation status
None (tested and no driver found)
|
22 Participants
n=5 Participants
|
|
Mutation status
Unknown
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1400 daysDocumented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: 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. criteria each year, until subject death
Outcome measures
| Measure |
Single Arm Trial
n=38 Participants
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Progression-free Survival
|
12.6 months
Interval 8.0 to 30.5
|
SECONDARY outcome
Timeframe: 1400 daysTime of enrollment to date of death.
Outcome measures
| Measure |
Single Arm Trial
n=38 Participants
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Overall Survival
|
20.3 months
Interval 15.8 to 30.5
|
SECONDARY outcome
Timeframe: 90 daysPopulation: All patients who received treatment were evaluated
Toxicity will be evaluated using CTCAE criteria, version 3, all grade 3 and 4 events.
Outcome measures
| Measure |
Single Arm Trial
n=38 Participants
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Subjects Experiencing Toxicity
Diarrhea
|
3 participants
|
|
Subjects Experiencing Toxicity
Dyspnea (shortness of breath)
|
2 participants
|
|
Subjects Experiencing Toxicity
Fatigue (asthenia, lethargy, malaise)
|
6 participants
|
|
Subjects Experiencing Toxicity
Hemoglobin
|
6 participants
|
|
Subjects Experiencing Toxicity
Hypertension
|
6 participants
|
|
Subjects Experiencing Toxicity
Leukocytes (total white blood cell count)
|
2 participants
|
|
Subjects Experiencing Toxicity
Lymphopenia
|
4 participants
|
|
Subjects Experiencing Toxicity
Nausea
|
2 participants
|
|
Subjects Experiencing Toxicity
Neutrophils/granulocytes (ANC/AGC)
|
7 participants
|
|
Subjects Experiencing Toxicity
Joint pain
|
2 participants
|
|
Subjects Experiencing Toxicity
Platelets
|
2 participants
|
|
Subjects Experiencing Toxicity
Vomiting
|
2 participants
|
Adverse Events
Single Arm Trial
Serious events: 14 serious events
Other events: 38 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Single Arm Trial
n=38 participants at risk
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Nervous system disorders
Ataxia (incoordination)
|
2.6%
1/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
2/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.9%
3/38 • Five years from registration
|
|
General disorders
Extremity-lower (gait/walking)
|
2.6%
1/38 • Five years from registration
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.6%
1/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.3%
2/38 • Five years from registration
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lung (pneumonia)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Kidney
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
2.6%
1/38 • Five years from registration
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
2.6%
1/38 • Five years from registration
|
|
General disorders
Pain - Pain NOS
|
2.6%
1/38 • Five years from registration
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
5.3%
2/38 • Five years from registration
|
|
Nervous system disorders
Syncope (fainting)
|
2.6%
1/38 • Five years from registration
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
2.6%
1/38 • Five years from registration
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
2.6%
1/38 • Five years from registration
|
Other adverse events
| Measure |
Single Arm Trial
n=38 participants at risk
Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride
bevacizumab: 15 mg/kg once per 21 day cycle (up to 4 cycles).
carboplatin: Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
erlotinib hydrochloride: 150mg, daily for 21 day cycle (up to 4 cycles)
pemetrexed disodium: 500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
15.8%
6/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
7.9%
3/38 • Five years from registration
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.5%
4/38 • Five years from registration
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
18.4%
7/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Anorexia
|
15.8%
6/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
2.6%
1/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.6%
1/38 • Five years from registration
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
23.7%
9/38 • Five years from registration
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
2.6%
1/38 • Five years from registration
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.6%
1/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.3%
2/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
2.6%
1/38 • Five years from registration
|
|
Psychiatric disorders
Confusion
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Constipation
|
36.8%
14/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
7/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Creatinine
|
13.2%
5/38 • Five years from registration
|
|
Gastrointestinal disorders
Dehydration
|
2.6%
1/38 • Five years from registration
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
7.9%
3/38 • Five years from registration
|
|
Gastrointestinal disorders
Diarrhea
|
21.1%
8/38 • Five years from registration
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
5.3%
2/38 • Five years from registration
|
|
Nervous system disorders
Dizziness
|
21.1%
8/38 • Five years from registration
|
|
Eye disorders
Dry eye syndrome
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.6%
1/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.4%
7/38 • Five years from registration
|
|
General disorders
Edema: head and neck
|
2.6%
1/38 • Five years from registration
|
|
General disorders
Edema: limb
|
18.4%
7/38 • Five years from registration
|
|
General disorders
Extremity-lower (gait/walking)
|
5.3%
2/38 • Five years from registration
|
|
Eye disorders
Eyelid dysfunction
|
2.6%
1/38 • Five years from registration
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
76.3%
29/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Febrile neutropenia(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
|
5.3%
2/38 • Five years from registration
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
13.2%
5/38 • Five years from registration
|
|
General disorders
Flu-like syndrome
|
2.6%
1/38 • Five years from registration
|
|
Vascular disorders
Flushing
|
2.6%
1/38 • Five years from registration
|
|
Renal and urinary disorders
Glomerular filtration rate
|
5.3%
2/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
28.9%
11/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
2.6%
1/38 • Five years from registration
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
7.9%
3/38 • Five years from registration
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.5%
4/38 • Five years from registration
|
|
Vascular disorders
Hematoma
|
2.6%
1/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
19/38 • Five years from registration
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
5.3%
2/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
10.5%
4/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
21.1%
8/38 • Five years from registration
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.3%
2/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.6%
1/38 • Five years from registration
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
7.9%
3/38 • Five years from registration
|
|
Vascular disorders
Hypertension
|
31.6%
12/38 • Five years from registration
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • Five years from registration
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Abdomen NOS
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lip/perioral
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Upper airway NOS
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Nose
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Kidney
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Middle ear (otitis media)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Oral cavity-gums (gingivitis)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Upper airway NOS
|
2.6%
1/38 • Five years from registration
|
|
Infections and infestations
Infection with unknown ANC - Urinary tract NOS
|
2.6%
1/38 • Five years from registration
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
2.6%
1/38 • Five years from registration
|
|
Psychiatric disorders
Insomnia
|
7.9%
3/38 • Five years from registration
|
|
Injury, poisoning and procedural complications
Intra-operative injury - Extremity-upper
|
2.6%
1/38 • Five years from registration
|
|
Injury, poisoning and procedural complications
Intra-operative Injury - Other (Specify, __)
|
2.6%
1/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
13.2%
5/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.8%
6/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
7.9%
3/38 • Five years from registration
|
|
Psychiatric disorders
Mood alteration - Depression
|
13.2%
5/38 • Five years from registration
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
7.9%
3/38 • Five years from registration
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
2.6%
1/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
2.6%
1/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
7.9%
3/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
2.6%
1/38 • Five years from registration
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.6%
1/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
5.3%
2/38 • Five years from registration
|
|
Gastrointestinal disorders
Nausea
|
55.3%
21/38 • Five years from registration
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
2.6%
1/38 • Five years from registration
|
|
Nervous system disorders
Neuropathy: cranial - CN II Vision
|
2.6%
1/38 • Five years from registration
|
|
Nervous system disorders
Neuropathy: cranial - CN VIII Hearing and balance
|
2.6%
1/38 • Five years from registration
|
|
Nervous system disorders
Neuropathy: sensory
|
2.6%
1/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
26.3%
10/38 • Five years from registration
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
5.3%
2/38 • Five years from registration
|
|
Ear and labyrinth disorders
Otitis, external ear (non-infectious)
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
5.3%
2/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.3%
2/38 • Five years from registration
|
|
Renal and urinary disorders
Pain - Bladder
|
5.3%
2/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
7.9%
3/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
7.9%
3/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest/thorax NOS
|
7.9%
3/38 • Five years from registration
|
|
Gastrointestinal disorders
Pain - Dental/teeth/peridontal
|
2.6%
1/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
15.8%
6/38 • Five years from registration
|
|
Nervous system disorders
Pain - Head/headache
|
23.7%
9/38 • Five years from registration
|
|
Gastrointestinal disorders
Pain - Intestine
|
2.6%
1/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
23.7%
9/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
2.6%
1/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
2.6%
1/38 • Five years from registration
|
|
General disorders
Pain - Other (Specify, __)
|
7.9%
3/38 • Five years from registration
|
|
General disorders
Pain - Pain NOS
|
7.9%
3/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Pain - Pelvis
|
2.6%
1/38 • Five years from registration
|
|
Gastrointestinal disorders
Pain - Rectum
|
5.3%
2/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Sinus
|
5.3%
2/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
7.9%
3/38 • Five years from registration
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.6%
1/38 • Five years from registration
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
5.3%
2/38 • Five years from registration
|
|
Blood and lymphatic system disorders
Platelets
|
18.4%
7/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.6%
1/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
1/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
7.9%
3/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.5%
4/38 • Five years from registration
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
2.6%
1/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
2.6%
1/38 • Five years from registration
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.9%
3/38 • Five years from registration
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
10.5%
4/38 • Five years from registration
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
13.2%
5/38 • Five years from registration
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis - Extremity-upper
|
2.6%
1/38 • Five years from registration
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
2.6%
1/38 • Five years from registration
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
2.6%
1/38 • Five years from registration
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/38 • Five years from registration
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.3%
2/38 • Five years from registration
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.6%
1/38 • Five years from registration
|
|
Eye disorders
Vision-blurred vision
|
5.3%
2/38 • Five years from registration
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
13.2%
5/38 • Five years from registration
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
9/38 • Five years from registration
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
7.9%
3/38 • Five years from registration
|
|
Investigations
Weight gain
|
2.6%
1/38 • Five years from registration
|
|
Investigations
Weight loss
|
10.5%
4/38 • Five years from registration
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place