Trial Outcomes & Findings for Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab (NCT NCT01814501)
NCT ID: NCT01814501
Last Updated: 2025-02-05
Results Overview
Continuous variables will be expressed by means, standard deviations and 95% confidence intervals. Estimated using the Kaplan-Meier estimator with confidence interval calculated based on the Brookmeyer-Crowley method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Time from study day 1 to the time the patient is first recorded as having disease progression or death, assessed up to 3 years
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab
Baseline characteristics by cohort
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 Participants
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 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
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 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
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from study day 1 to the time the patient is first recorded as having disease progression or death, assessed up to 3 yearsContinuous variables will be expressed by means, standard deviations and 95% confidence intervals. Estimated using the Kaplan-Meier estimator with confidence interval calculated based on the Brookmeyer-Crowley method.
Outcome measures
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 Participants
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Progression Free Survival (PFS)
|
255.921 days to progression
Interval 189.162 to 322.68
|
SECONDARY outcome
Timeframe: Up to 3 yearsFrequencies will be computed for discrete data. Toxicities graded per NCI CTCAE v4.0 grade 3, 4, 5
Outcome measures
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 Participants
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Increased ALT
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Increased AST
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Diarrhea
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Fatigue
|
12.5 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Gastrointestional disorders
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Hypertension
|
12.5 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Hypokalemia
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Hypomagnesemia
|
12.5 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Hyponatremia
|
12.5 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Lymphocyte count decreased
|
12.5 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Lymphocyte count increased
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Mucositis oral
|
25 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Neoplasms benign, malignant and unspecified
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Neutrophil count decreased
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Palmar-plantar erythrodysesthesia syndrome
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Pruritus
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Skin and subcutaneous tissue disorders
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
Sleep apnea
|
6.3 percentage of patients
|
|
Frequency and Severity of Toxicities of the Regimens, Graded According to the NCI CTCAE v4.0
White blood cell decreased
|
6.3 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 Participants
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Proportion of Participants With Overall Response Rate, as Described in RECIST v1.1 Criteria
|
0.1875 proportion of participants
Interval 0.0405 to 0.4565
|
SECONDARY outcome
Timeframe: Time from study day 1 to the date of death or the last date the patient was known to be alive, assessed up to 3 yearsContinuous variables will be expressed by means, standard deviations and 95% confidence intervals. Kaplan-Meier estimator will be used.
Outcome measures
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 Participants
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Overall Survival
|
471 days
Interval 32.34 to 909.66
|
Adverse Events
Treatment (Panitumumab, Combination Chemotherapy)
Serious events: 16 serious events
Other events: 16 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 participants at risk
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Lymphocyte count increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
White blood cell decreased
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
Other adverse events
| Measure |
Treatment (Panitumumab, Combination Chemotherapy)
n=16 participants at risk
5-Fluorouracil, irinotecan, and panitumumab
panitumumab: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
leucovorin calcium: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
8/16 • Number of events 8 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
31.2%
5/16 • Number of events 5 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Alkaline phosphatase increased
|
31.2%
5/16 • Number of events 5 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Blood and lymphatic system disorders
Anemia
|
81.2%
13/16 • Number of events 13 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
6/16 • Number of events 6 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
6/16 • Number of events 6 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Eye disorders
Blurred vision
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Eye disorders
Cataract
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
56.2%
9/16 • Number of events 9 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
General disorders
Edema face
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
50.0%
8/16 • Number of events 8 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Eye disorders
Eye disorders - Other, specify
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
81.2%
13/16 • Number of events 13 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Immune system disorders
Infusion related reaction
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
INR increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Localized edema
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
8/16 • Number of events 8 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Nausea
|
56.2%
9/16 • Number of events 9 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Neutrophil count decreased
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Nervous system disorders
Paresthesia
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Platelet count decreased
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
6/16 • Number of events 6 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
62.5%
10/16 • Number of events 10 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
31.2%
5/16 • Number of events 5 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Rectal pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
43.8%
7/16 • Number of events 7 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Renal and urinary disorders
Urinary urgency
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
Weight loss
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
|
Investigations
White blood cell decreased
|
37.5%
6/16 • Number of events 6 • Adverse Events were assessed from baseline to study follow-up using the National Cancer Institute (NCI) CTCAE version 4.0, an average of 4 years.
|
Additional Information
Dr. John Hays
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place