Trial Outcomes & Findings for Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck (NCT NCT02979977)
NCT ID: NCT02979977
Last Updated: 2026-02-04
Results Overview
Objective Response Rate (Complete Response + Partial Response), defined by tumor shrinkage (mm), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. RECIST v1.1 Response Categories are as follows: Complete Response (CR) - all pathological lymph nodes must be \< 10 mm in short axis; Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) - The cancer has neither clearly improved nor worsened. Progressive Disease (PD) - at least a 20% increase in the sum of diameters of target lesions AND an absolute increase of ≥ 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Disease progression or end of treatment (up to 2 years)
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
All Subjects
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Off Treatment
|
49
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
All Subjects
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Disease Progression
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck
Baseline characteristics by cohort
| Measure |
All Subjects
n=50 Participants
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Age, Continuous
|
63 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=41 Participants
|
|
P16 Status
Negative
|
29 Participants
n=41 Participants
|
|
P16 Status
Positive
|
21 Participants
n=41 Participants
|
|
Prior Lines of Treatment
Platinum
|
49 Participants
n=41 Participants
|
|
Prior Lines of Treatment
Anti-PD-1
|
37 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Disease progression or end of treatment (up to 2 years)Population: Those who were response-evaluable.
Objective Response Rate (Complete Response + Partial Response), defined by tumor shrinkage (mm), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. RECIST v1.1 Response Categories are as follows: Complete Response (CR) - all pathological lymph nodes must be \< 10 mm in short axis; Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) - The cancer has neither clearly improved nor worsened. Progressive Disease (PD) - at least a 20% increase in the sum of diameters of target lesions AND an absolute increase of ≥ 5 mm.
Outcome measures
| Measure |
All Subjects
n=47 Participants
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Tumor Shrinkage
Complete Responses (CR)
|
2 Participants
|
|
Tumor Shrinkage
Partial Response (PR)
|
9 Participants
|
|
Tumor Shrinkage
No Response
|
36 Participants
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Those that were response evaluable.
We will use Kaplan-Meier survival analysis to estimate the median PFS in the cohort. Data are presented by P16 status. The outcome measure title was updated to present the data in months, as analyzed, instead of weeks as originally registered.
Outcome measures
| Measure |
All Subjects
n=47 Participants
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Progression-free Survival in Months
P16 Negative
|
3.8 months
Interval 2.1 to
Not enough events to calculate the upper bound CI.
|
|
Progression-free Survival in Months
P16 Positive
|
7.5 months
Interval 4.8 to 12.0
|
SECONDARY outcome
Timeframe: 1 year follow-upPopulation: Those with an evaluable response.
Measured by a monthly phone calls. We will use Kaplan-Meier survival analysis to estimate the median and OS in the cohort.
Outcome measures
| Measure |
All Subjects
n=47 Participants
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Overall Survival in Months
|
7.5 months
Interval 4.8 to 12.0
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Only in those with a measurable response.
Presented is the time from treatment onset until best response.
Outcome measures
| Measure |
All Subjects
n=11 Participants
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Duration of Response in Weeks
|
20.4 weeks
Interval 1.0 to 293.4
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsPopulation: All those consented.
Presented are a count of those that experienced at least 1 adverse event. Adverse event details are presented in the Adverse Events module.
Outcome measures
| Measure |
All Subjects
n=50 Participants
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Toxicity Assessed With National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
49 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsAnalysis of tumor-tissue from biopsies obtained at baseline, after four weeks of treatment with the combination, and again at disease progression or end of treatment
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious events: 20 serious events
Other events: 49 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
All Subjects
n=50 participants at risk
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Gastric perforation
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Fever
|
4.0%
2/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Infusion related reaction
|
4.0%
2/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Pain
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Larygeal Edema
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Immune system disorders
Anaphylaxis
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Infections and infestations
Skin infection
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.0%
2/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Investigations
Cancer of new histology
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Skin and subcutaneous tissue disorders
Skin peeling
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
Other adverse events
| Measure |
All Subjects
n=50 participants at risk
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
cetuximab: 30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
afatinib: Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.0%
6/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Nervous system disorders
Headache
|
10.0%
5/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Nervous system disorders
Dysgeusia
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Psychiatric disorders
Insomnia
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Psychiatric disorders
Anxiety
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
10/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
70.0%
35/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Blood and lymphatic system disorders
Anemia
|
36.0%
18/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
18.0%
9/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Diarrhea
|
48.0%
24/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Mucositis oral
|
24.0%
12/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Nausea
|
22.0%
11/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.0%
7/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Constipation
|
14.0%
7/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Dysphagia
|
12.0%
6/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Fatigue
|
30.0%
15/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Pain
|
12.0%
6/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
General disorders
Infusion related reaction
|
12.0%
6/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Infections and infestations
Paronychia
|
14.0%
7/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Infections and infestations
Skin infection
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Infections and infestations
Upper respiratory infection
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Investigations
Weight loss
|
18.0%
9/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
8/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Investigations
Alkaline phosphatase increased
|
14.0%
7/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
5/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Investigations
Lymphocyte count decreased
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.0%
14/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
24.0%
12/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.0%
8/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
4/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
18.0%
9/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.0%
9/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.0%
8/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
3/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Vascular disorders
Hypotension
|
16.0%
8/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
|
Vascular disorders
Hypertension
|
12.0%
6/50 • Up to 2.5 years
All cause mortality is reported as death within 2.5 years of participants being placed on study.
|
Additional Information
Aarti Bhatia, MD, MPH, Associate Professor of Medicine (Medical Oncology)
Yale University School of Medicine
Phone: (203) 200-4622
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place