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S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438722
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Results First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Interventions Drug: Afatinib Dimaleate
Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Enrollment 174
Recruitment Details  
Pre-assignment Details

174 participants were enrolled, however, 6 were deemed ineligible. Thus, 168 participants were eligible and randomized.

5 participants on arm 1 did not receive protocol therapy.

Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 83 85
Participants Evaluable for Adverse Events 78 85
Completed 0 0
Not Completed 83 85
Reason Not Completed
Adverse Event             12             9
Refusal unrelated to AE             2             5
Disease progression/relapse             46             51
Death             0             3
Physician Decision             2             2
Exceeded protocol-specified maximum treatment delay unrelated to AE             1             0
Withdrawal by Subject             0             1
On protocol treatment             15             14
Did not receive protocol treatment             5             0
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate) Total
Hide Arm/Group Description

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 83 85 168
Hide Baseline Analysis Population Description
Eligible participants that were randomized to study arms
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 83 participants 85 participants 168 participants
65.5
(27.9 to 90.5)
66.3
(39.3 to 93.0)
66.0
(27.9 to 93.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Female
59
  71.1%
53
  62.4%
112
  66.7%
Male
24
  28.9%
32
  37.6%
56
  33.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Asian
11
  13.3%
10
  11.8%
21
  12.5%
Black
3
   3.6%
8
   9.4%
11
   6.5%
Multiracial
1
   1.2%
0
   0.0%
1
   0.6%
Native American
2
   2.4%
0
   0.0%
2
   1.2%
Pacific Islander
0
   0.0%
1
   1.2%
1
   0.6%
White
59
  71.1%
63
  74.1%
122
  72.6%
Unknown
7
   8.4%
3
   3.5%
10
   6.0%
Hispanic
9
  10.8%
8
   9.4%
17
  10.1%
Performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
0
38
  45.8%
32
  37.6%
70
  41.7%
1
36
  43.4%
47
  55.3%
83
  49.4%
2
9
  10.8%
6
   7.1%
15
   8.9%
[1]
Measure Description:

Participants were graded according to the Zubrod Performance Status Scale.

0- Fully active, able to carry out on all pre-disease performance without restriction.

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work.
  2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
EGFR mutation type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Exon 19 deletion
53
  63.9%
54
  63.5%
107
  63.7%
L858R mutation
30
  36.1%
31
  36.5%
61
  36.3%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Adenocarcinoma
80
  96.4%
81
  95.3%
161
  95.8%
Large cell
0
   0.0%
1
   1.2%
1
   0.6%
Squamous
3
   3.6%
0
   0.0%
3
   1.8%
Mixed (>= 50% squamous)
0
   0.0%
1
   1.2%
1
   0.6%
Mixed (< 50% squamous)
0
   0.0%
1
   1.2%
1
   0.6%
Other non-small cell
0
   0.0%
1
   1.2%
1
   0.6%
Smoking history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Current smoker
8
   9.6%
6
   7.1%
14
   8.3%
Former smoker
32
  38.6%
32
  37.6%
64
  38.1%
Never smoker
43
  51.8%
47
  55.3%
90
  53.6%
Weight loss in the last 6 months, %  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
<5
57
  68.7%
57
  67.1%
114
  67.9%
5-10
13
  15.7%
15
  17.6%
28
  16.7%
10-20
12
  14.5%
9
  10.6%
21
  12.5%
>=20
0
   0.0%
1
   1.2%
1
   0.6%
Data Missing
1
   1.2%
3
   3.5%
4
   2.4%
Brain metastases  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
27
  32.5%
21
  24.7%
48
  28.6%
1.Primary Outcome
Title 2-year Overall Survival Rate
Hide Description

Percentage of participants still alive 2 years post registration.

KM estimate at 2 years is presented, Overall Survival assessed for a total of 3 years in order to calculate value.

Time Frame Up to 3 years post registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants that were randomized to study arms.
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description:

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 83 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(55 to 76)
70
(58 to 79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Afatinib Dimaleate, Cetuximab), Arm II (Afatinib Dimaleate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.50 to 1.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title Progression-Free Survival
Hide Description

From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.

Time Frame up to 3 years post registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants that were randomized to study arms.
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description:

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 83 85
Median (95% Confidence Interval)
Unit of Measure: months
11.9
(9.9 to 17.8)
13.4
(9.3 to 14.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Afatinib Dimaleate, Cetuximab), Arm II (Afatinib Dimaleate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.72 to 1.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Response Rates
Hide Description

Percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of appropriate diameters of all target measurable lesions; Overall Response (OR) = CR + PR.

Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants that were randomized to study arms and who had baseline measurable disease (153)
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description:

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 76 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(55 to 77)
74
(63 to 83)
4.Secondary Outcome
Title Time to Treatment Discontinuation
Hide Description From date of registration to date of discontinuation of treatment or death due to any cause
Time Frame up to 3 years post-registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who were randomized to study arms.
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description:

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 83 85
Median (95% Confidence Interval)
Unit of Measure: months
12.7
(10.8 to 17.6)
12.2
(9.3 to 15.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Afatinib Dimaleate, Cetuximab), Arm II (Afatinib Dimaleate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.64 to 1.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Treatment Failure
Hide Description From date of registration to date of first documentation of progression or symptomatic deterioration, early discontinuation of treatment, or death due to any cause.
Time Frame assessed up to 3 years post registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who were randomized to study arms.
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description:

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 83 85
Median (95% Confidence Interval)
Unit of Measure: months
10.8
(7.7 to 12.9)
10.0
(7.1 to 13.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Afatinib Dimaleate, Cetuximab), Arm II (Afatinib Dimaleate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.73 to 1.39
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hide Description Routine Adverse Events are reported by CTCAE4.0. For serious adverse event reporting, we updated from CTCAE4.0 to CTCAE5.0. . Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Duration of treatment and follow up until death or 3 years post registration
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least one dose of protocol treatment.
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description:

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 78 85
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 1 0
Acidosis 1 0
Acute kidney injury 1 1
Alanine aminotransferase increased 1 1
Alkaline phosphatase increased 1 1
Allergic reaction 2 0
Anemia 1 1
Anorexia 0 1
Aspartate aminotransferase increased 1 0
Atrial fibrillation 0 1
Back pain 1 0
Bullous dermatitis 1 0
Chills 1 0
Cough 1 0
Creatinine increased 0 2
Dehydration 2 2
Diarrhea 12 17
Dry skin 3 0
Dyspepsia 1 0
Dyspnea 2 0
Encephalopathy 0 1
Enterocolitis infectious 0 1
Fatigue 1 1
Flank pain 1 0
General disorders and admin site conditions - Other 0 1
Hypertension 0 1
Hypocalcemia 1 0
Hypokalemia 5 5
Hypomagnesemia 1 0
Hyponatremia 0 1
Hypophosphatemia 1 0
Hypotension 1 0
Hypoxia 1 0
Infections and infestations - Other, specify 1 0
Infusion related reaction 2 0
Lipase increased 0 1
Lung infection 1 0
Lymphocyte count decreased 1 2
Lymphocyte count increased 0 1
Mucositis oral 6 4
Nausea 2 3
Oral pain 0 1
Palmar-plantar erythrodysesthesia syndrome 0 1
Papulopustular rash 2 0
Paronychia 4 1
Pneumonitis 3 0
Pruritus 3 1
Rash acneiform 21 2
Rash maculo-papular 10 0
Rash pustular 1 0
Sepsis 0 1
Skin and subcutaneous tissue disorders - Other 1 0
Skin infection 0 1
Thromboembolic event 1 0
Urticaria 1 0
Vomiting 0 1
Weight loss 1 0
7.Other Pre-specified Outcome
Title Change in Copy Number Alterations in MET, EGFR, and HER2, Analyzed Using Fluorescence in Situ Hybridization
Hide Description For each of these markers, a one-sample t-test (or Wilcoxon signed-rank test) will be used to test the null hypothesis that the absolute difference between the copy number after progression and the copy number in the pre-treatment specimen (or an appropriate transformation of the difference, determined after exploratory data analysis) is not equal to zero.
Time Frame Baseline up to 3 years (after disease progression)
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Change in the Ratio of Sensitizing EGFR Mutation to EGFR T790 Mutation
Hide Description To evaluate if EGFRs/EGFR T790M is lower at progression than in pre-treatment specimens among patients with results available for pre-treatment and progression, a one-sample t-test (or Wilcoxon signed-rank test) will be used to test the null hypothesis that the difference between the progression ratio and the pre-treatment ratio (or an appropriate transformation of the difference, determined after exploratory data analysis) is greater than zero in favor of the alternative that the difference is less than zero.
Time Frame Baseline up to 3 years (at progression)
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title EGFR Immunohistochemistry H-score
Hide Description To evaluate the hypothesis that H-score positive status at baseline is associated with absolute difference in PFS (and OS) among patients randomized to receive afatinib dimaleate monotherapy a test of interaction will be performed at the 1-sided 20% level.
Time Frame Baseline
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Levels of Circulating Tumor Markers
Hide Description Tumor marker levels over time will be evaluated using a linear mixed model for continuous markers and using generalized estimating equations for binary markers. A landmark analysis will be used to evaluate the correlation between post-randomization biomarker values and PFS and OS (from the landmark timepoint) using a Cox proportional hazards model.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Presence of de Novo EGFR T790M Mutation or Other Molecular Alterations
Hide Description To evaluate if the presence of de novo T790M mutation is associated with primary resistance to afatinib dimaleate, PFS and OS will be compared between T790M mutation positive and negative patients randomized to the afatinib dimaleate monotherapy arm using a log-rank test..
Time Frame Baseline
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Ratio of Sensitizing EGFR Mutation to EGFR T790 Mutation
Hide Description To evaluate if the ratio of EGFR sensitizing mutation to EGFR T790M mutation (EGFRs/EGFR T790M) among patients with T790M is predictive for afatinib dimaleate monotherapy, analyses will be performed in a similar fashion to the evaluation of T790M among patients with measurable T790M (which defines T790M). Cox regression will be used to assess the predictive association of the ratio in the afatinib dimaleate monotherapy arm with both OS and PFS
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame Duration of treatment and follow up until death or 3 years post registration
Adverse Event Reporting Description Of 168 eligible participants, 5 did not receive protocol therapy so were not assessed for AEs. Therefore only 163 participants (78 on arm 1 and 85 on arm 2) were assessed for AEs. All eligible participants were assessed for All-Cause Mortality.
 
Arm/Group Title Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Hide Arm/Group Description

Participants receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Cetuximab: Given IV

Laboratory Biomarker Analysis: Correlative studies

Participants receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Afatinib Dimaleate: Given PO

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Affected / at Risk (%) Affected / at Risk (%)
Total   30/83 (36.14%)   35/85 (41.18%) 
Hide Serious Adverse Events
Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Affected / at Risk (%) Affected / at Risk (%)
Total   29/78 (37.18%)   30/85 (35.29%) 
Blood and lymphatic system disorders     
Anemia   1/78 (1.28%)  1/85 (1.18%) 
Lymph node pain   0/78 (0.00%)  1/85 (1.18%) 
Cardiac disorders     
Atrial fibrillation   0/78 (0.00%)  1/85 (1.18%) 
Pericardial effusion   1/78 (1.28%)  0/85 (0.00%) 
Gastrointestinal disorders     
Abdominal pain   1/78 (1.28%)  2/85 (2.35%) 
Constipation   1/78 (1.28%)  0/85 (0.00%) 
Diarrhea   3/78 (3.85%)  7/85 (8.24%) 
Esophageal ulcer   0/78 (0.00%)  1/85 (1.18%) 
Gastritis   0/78 (0.00%)  1/85 (1.18%) 
Gastrointestinal disorders-Other   0/78 (0.00%)  1/85 (1.18%) 
Mucositis oral   1/78 (1.28%)  0/85 (0.00%) 
Nausea   1/78 (1.28%)  4/85 (4.71%) 
Pancreatitis   0/78 (0.00%)  1/85 (1.18%) 
Vomiting   0/78 (0.00%)  3/85 (3.53%) 
General disorders     
Death NOS   0/78 (0.00%)  2/85 (2.35%) 
Multi-organ failure   0/78 (0.00%)  1/85 (1.18%) 
Non-cardiac chest pain   0/78 (0.00%)  1/85 (1.18%) 
Pain   1/78 (1.28%)  0/85 (0.00%) 
Hepatobiliary disorders     
Cholecystitis   0/78 (0.00%)  2/85 (2.35%) 
Immune system disorders     
Allergic reaction   1/78 (1.28%)  0/85 (0.00%) 
Infections and infestations     
Appendicitis   1/78 (1.28%)  0/85 (0.00%) 
Catheter related infection   1/78 (1.28%)  0/85 (0.00%) 
Enterocolitis infectious   0/78 (0.00%)  1/85 (1.18%) 
Infections and infestations-Other   1/78 (1.28%)  1/85 (1.18%) 
Lung infection   2/78 (2.56%)  2/85 (2.35%) 
Paronychia   1/78 (1.28%)  0/85 (0.00%) 
Sepsis   0/78 (0.00%)  2/85 (2.35%) 
Skin infection   1/78 (1.28%)  1/85 (1.18%) 
Urinary tract infection   0/78 (0.00%)  2/85 (2.35%) 
Injury, poisoning and procedural complications     
Fall   0/78 (0.00%)  2/85 (2.35%) 
Fracture   1/78 (1.28%)  0/85 (0.00%) 
Vascular access complication   0/78 (0.00%)  1/85 (1.18%) 
Wrist fracture   0/78 (0.00%)  1/85 (1.18%) 
Investigations     
Alanine aminotransferase increased   1/78 (1.28%)  0/85 (0.00%) 
Alkaline phosphatase increased   1/78 (1.28%)  0/85 (0.00%) 
Aspartate aminotransferase increased   1/78 (1.28%)  1/85 (1.18%) 
Blood bilirubin increased   1/78 (1.28%)  0/85 (0.00%) 
Creatinine increased   1/78 (1.28%)  1/85 (1.18%) 
Lymphocyte count decreased   1/78 (1.28%)  0/85 (0.00%) 
Weight loss   0/78 (0.00%)  1/85 (1.18%) 
Metabolism and nutrition disorders     
Acidosis   1/78 (1.28%)  0/85 (0.00%) 
Anorexia   1/78 (1.28%)  1/85 (1.18%) 
Dehydration   2/78 (2.56%)  5/85 (5.88%) 
Hyperkalemia   1/78 (1.28%)  0/85 (0.00%) 
Hypoalbuminemia   0/78 (0.00%)  1/85 (1.18%) 
Hypokalemia   1/78 (1.28%)  3/85 (3.53%) 
Hyponatremia   1/78 (1.28%)  1/85 (1.18%) 
Musculoskeletal and connective tissue disorders     
Chest wall pain   0/78 (0.00%)  1/85 (1.18%) 
Generalized muscle weakness   0/78 (0.00%)  2/85 (2.35%) 
Osteonecrosis of jaw   1/78 (1.28%)  0/85 (0.00%) 
Pain in extremity   0/78 (0.00%)  1/85 (1.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other   3/78 (3.85%)  0/85 (0.00%) 
Nervous system disorders     
Dizziness   0/78 (0.00%)  1/85 (1.18%) 
Dysarthria   1/78 (1.28%)  0/85 (0.00%) 
Encephalopathy   0/78 (0.00%)  4/85 (4.71%) 
Headache   0/78 (0.00%)  2/85 (2.35%) 
Lethargy   1/78 (1.28%)  0/85 (0.00%) 
Nervous system disorders-Other   1/78 (1.28%)  0/85 (0.00%) 
Paresthesia   1/78 (1.28%)  0/85 (0.00%) 
Seizure   1/78 (1.28%)  1/85 (1.18%) 
Stroke   1/78 (1.28%)  1/85 (1.18%) 
Psychiatric disorders     
Anxiety   1/78 (1.28%)  0/85 (0.00%) 
Confusion   0/78 (0.00%)  3/85 (3.53%) 
Depression   0/78 (0.00%)  1/85 (1.18%) 
Renal and urinary disorders     
Acute kidney injury   3/78 (3.85%)  1/85 (1.18%) 
Hematuria   1/78 (1.28%)  0/85 (0.00%) 
Renal and urinary disorders-Other   1/78 (1.28%)  0/85 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome   0/78 (0.00%)  1/85 (1.18%) 
Dyspnea   3/78 (3.85%)  1/85 (1.18%) 
Hypoxia   2/78 (2.56%)  0/85 (0.00%) 
Pleural effusion   2/78 (2.56%)  2/85 (2.35%) 
Pneumonitis   2/78 (2.56%)  1/85 (1.18%) 
Pneumothorax   1/78 (1.28%)  2/85 (2.35%) 
Respiratory failure   0/78 (0.00%)  1/85 (1.18%) 
Skin and subcutaneous tissue disorders     
Rash acneiform   2/78 (2.56%)  0/85 (0.00%) 
Rash maculo-papular   2/78 (2.56%)  0/85 (0.00%) 
Vascular disorders     
Hypertension   0/78 (0.00%)  1/85 (1.18%) 
Hypotension   1/78 (1.28%)  0/85 (0.00%) 
Thromboembolic event   5/78 (6.41%)  2/85 (2.35%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Afatinib Dimaleate, Cetuximab) Arm II (Afatinib Dimaleate)
Affected / at Risk (%) Affected / at Risk (%)
Total   78/78 (100.00%)   84/85 (98.82%) 
Blood and lymphatic system disorders     
Anemia   28/78 (35.90%)  32/85 (37.65%) 
Blood and lymphatic system disorders - Other   4/78 (5.13%)  4/85 (4.71%) 
Cardiac disorders     
Atrial fibrillation   1/78 (1.28%)  1/85 (1.18%) 
Cardiac disorders-Other   4/78 (5.13%)  0/85 (0.00%) 
Chest pain - cardiac   0/78 (0.00%)  2/85 (2.35%) 
Palpitations   1/78 (1.28%)  1/85 (1.18%) 
Sinus tachycardia   4/78 (5.13%)  6/85 (7.06%) 
Congenital, familial and genetic disorders     
Congenital, familial and genetic disorders - Other   1/78 (1.28%)  0/85 (0.00%) 
Ear and labyrinth disorders     
Ear and labyrinth disorders-Other   2/78 (2.56%)  0/85 (0.00%) 
Ear pain   1/78 (1.28%)  5/85 (5.88%) 
External ear inflammation   1/78 (1.28%)  0/85 (0.00%) 
Hearing impaired   2/78 (2.56%)  0/85 (0.00%) 
Tinnitus   1/78 (1.28%)  0/85 (0.00%) 
Vertigo   2/78 (2.56%)  0/85 (0.00%) 
Endocrine disorders     
Cushingoid   0/78 (0.00%)  1/85 (1.18%) 
Endocrine disorders-Other   0/78 (0.00%)  1/85 (1.18%) 
Eye disorders     
Blurred vision   11/78 (14.10%)  9/85 (10.59%) 
Cataract   1/78 (1.28%)  0/85 (0.00%) 
Conjunctivitis   13/78 (16.67%)  7/85 (8.24%) 
Corneal ulcer   1/78 (1.28%)  0/85 (0.00%) 
Dry eye   19/78 (24.36%)  15/85 (17.65%) 
Eye disorders-Other   9/78 (11.54%)  10/85 (11.76%) 
Eye pain   1/78 (1.28%)  3/85 (3.53%) 
Eyelid function disorder   1/78 (1.28%)  0/85 (0.00%) 
Floaters   0/78 (0.00%)  1/85 (1.18%) 
Keratitis   2/78 (2.56%)  0/85 (0.00%) 
Photophobia   0/78 (0.00%)  2/85 (2.35%) 
Vitreous hemorrhage   0/78 (0.00%)  1/85 (1.18%) 
Watering eyes   9/78 (11.54%)  9/85 (10.59%) 
Gastrointestinal disorders     
Abdominal distension   1/78 (1.28%)  1/85 (1.18%) 
Abdominal pain   13/78 (16.67%)  9/85 (10.59%) 
Anal hemorrhage   1/78 (1.28%)  0/85 (0.00%) 
Bloating   2/78 (2.56%)  1/85 (1.18%) 
Cheilitis   6/78 (7.69%)  8/85 (9.41%) 
Constipation   31/78 (39.74%)  17/85 (20.00%) 
Diarrhea   73/78 (93.59%)  78/85 (91.76%) 
Dry mouth   10/78 (12.82%)  14/85 (16.47%) 
Duodenal ulcer   0/78 (0.00%)  1/85 (1.18%) 
Dyspepsia   8/78 (10.26%)  8/85 (9.41%) 
Dysphagia   2/78 (2.56%)  8/85 (9.41%) 
Enterocolitis   0/78 (0.00%)  1/85 (1.18%) 
Esophageal pain   1/78 (1.28%)  0/85 (0.00%) 
Esophagitis   2/78 (2.56%)  3/85 (3.53%) 
Flatulence   2/78 (2.56%)  2/85 (2.35%) 
Gastritis   0/78 (0.00%)  3/85 (3.53%) 
Gastroesophageal reflux disease   8/78 (10.26%)  8/85 (9.41%) 
Gastrointestinal disorders-Other   8/78 (10.26%)  10/85 (11.76%) 
Gastrointestinal pain   2/78 (2.56%)  0/85 (0.00%) 
Gingival pain   1/78 (1.28%)  0/85 (0.00%) 
Hemorrhoidal hemorrhage   0/78 (0.00%)  1/85 (1.18%) 
Hemorrhoids   3/78 (3.85%)  2/85 (2.35%) 
Lip pain   0/78 (0.00%)  1/85 (1.18%) 
Mucositis oral   38/78 (48.72%)  39/85 (45.88%) 
Nausea   44/78 (56.41%)  34/85 (40.00%) 
Oral hemorrhage   1/78 (1.28%)  1/85 (1.18%) 
Oral pain   4/78 (5.13%)  2/85 (2.35%) 
Periodontal disease   1/78 (1.28%)  0/85 (0.00%) 
Rectal hemorrhage   2/78 (2.56%)  0/85 (0.00%) 
Small intestinal stenosis   1/78 (1.28%)  0/85 (0.00%) 
Stomach pain   1/78 (1.28%)  4/85 (4.71%) 
Tooth discoloration   0/78 (0.00%)  1/85 (1.18%) 
Toothache   1/78 (1.28%)  2/85 (2.35%) 
Upper gastrointestinal hemorrhage   0/78 (0.00%)  1/85 (1.18%) 
Vomiting   31/78 (39.74%)  21/85 (24.71%) 
General disorders     
Chills   11/78 (14.10%)  4/85 (4.71%) 
Edema face   2/78 (2.56%)  0/85 (0.00%) 
Edema limbs   15/78 (19.23%)  17/85 (20.00%) 
Fatigue   58/78 (74.36%)  49/85 (57.65%) 
Fever   10/78 (12.82%)  8/85 (9.41%) 
Flu like symptoms   7/78 (8.97%)  8/85 (9.41%) 
Gait disturbance   1/78 (1.28%)  2/85 (2.35%) 
General disorders and admin site conditions - Other   11/78 (14.10%)  9/85 (10.59%) 
Infusion related reaction   7/78 (8.97%)  0/85 (0.00%) 
Infusion site extravasation   1/78 (1.28%)  0/85 (0.00%) 
Irritability   1/78 (1.28%)  1/85 (1.18%) 
Localized edema   2/78 (2.56%)  0/85 (0.00%) 
Malaise   1/78 (1.28%)  1/85 (1.18%) 
Neck edema   1/78 (1.28%)  0/85 (0.00%) 
Non-cardiac chest pain   7/78 (8.97%)  7/85 (8.24%) 
Pain   20/78 (25.64%)  14/85 (16.47%) 
Hepatobiliary disorders     
Hepatobiliary disorders-Other   0/78 (0.00%)  1/85 (1.18%) 
Immune system disorders     
Allergic reaction   5/78 (6.41%)  0/85 (0.00%) 
Immune system disorders-Other   0/78 (0.00%)  1/85 (1.18%) 
Infections and infestations     
Bladder infection   0/78 (0.00%)  2/85 (2.35%) 
Bronchial infection   3/78 (3.85%)  2/85 (2.35%) 
Catheter related infection   0/78 (0.00%)  1/85 (1.18%) 
Conjunctivitis infective   1/78 (1.28%)  0/85 (0.00%) 
Enterocolitis infectious   1/78 (1.28%)  1/85 (1.18%) 
Eye infection   1/78 (1.28%)  1/85 (1.18%) 
Infections and infestations-Other   11/78 (14.10%)  17/85 (20.00%) 
Laryngitis   2/78 (2.56%)  0/85 (0.00%) 
Lung infection   1/78 (1.28%)  0/85 (0.00%) 
Mucosal infection   2/78 (2.56%)  0/85 (0.00%) 
Nail infection   2/78 (2.56%)  2/85 (2.35%) 
Otitis media   1/78 (1.28%)  1/85 (1.18%) 
Papulopustular rash   7/78 (8.97%)  5/85 (5.88%) 
Paronychia   39/78 (50.00%)  34/85 (40.00%) 
Pelvic infection   1/78 (1.28%)  0/85 (0.00%) 
Rash pustular   4/78 (5.13%)  0/85 (0.00%) 
Rhinitis infective   1/78 (1.28%)  0/85 (0.00%) 
Sinusitis   2/78 (2.56%)  7/85 (8.24%) 
Skin infection   10/78 (12.82%)  8/85 (9.41%) 
Tooth infection   0/78 (0.00%)  2/85 (2.35%) 
Upper respiratory infection   7/78 (8.97%)  6/85 (7.06%) 
Urinary tract infection   10/78 (12.82%)  16/85 (18.82%) 
Vaginal infection   3/78 (3.85%)  2/85 (2.35%) 
Wound infection   0/78 (0.00%)  1/85 (1.18%) 
Injury, poisoning and procedural complications     
Bruising   3/78 (3.85%)  3/85 (3.53%) 
Burn   0/78 (0.00%)  1/85 (1.18%) 
Dermatitis radiation   0/78 (0.00%)  1/85 (1.18%) 
Fall   5/78 (6.41%)  2/85 (2.35%) 
Fracture   1/78 (1.28%)  3/85 (3.53%) 
Injury, poison and procedural complications - Other   2/78 (2.56%)  2/85 (2.35%) 
Radiation recall reaction (dermatologic)   0/78 (0.00%)  1/85 (1.18%) 
Spinal fracture   1/78 (1.28%)  0/85 (0.00%) 
Investigations     
Alanine aminotransferase increased   21/78 (26.92%)  24/85 (28.24%) 
Alkaline phosphatase increased   22/78 (28.21%)  23/85 (27.06%) 
Aspartate aminotransferase increased   27/78 (34.62%)  23/85 (27.06%) 
Blood bilirubin increased   9/78 (11.54%)  9/85 (10.59%) 
Cholesterol high   1/78 (1.28%)  0/85 (0.00%) 
Creatinine increased   14/78 (17.95%)  21/85 (24.71%) 
INR increased   1/78 (1.28%)  1/85 (1.18%) 
Investigations-Other   3/78 (3.85%)  9/85 (10.59%) 
Lipase increased   0/78 (0.00%)  2/85 (2.35%) 
Lymphocyte count decreased   18/78 (23.08%)  14/85 (16.47%) 
Lymphocyte count increased   1/78 (1.28%)  1/85 (1.18%) 
Neutrophil count decreased   4/78 (5.13%)  5/85 (5.88%) 
Platelet count decreased   3/78 (3.85%)  6/85 (7.06%) 
Weight gain   6/78 (7.69%)  5/85 (5.88%) 
Weight loss   22/78 (28.21%)  29/85 (34.12%) 
White blood cell decreased   13/78 (16.67%)  10/85 (11.76%) 
Metabolism and nutrition disorders     
Anorexia   30/78 (38.46%)  31/85 (36.47%) 
Dehydration   6/78 (7.69%)  4/85 (4.71%) 
Glucose intolerance   1/78 (1.28%)  0/85 (0.00%) 
Hypercalcemia   1/78 (1.28%)  3/85 (3.53%) 
Hyperglycemia   17/78 (21.79%)  20/85 (23.53%) 
Hyperkalemia   7/78 (8.97%)  5/85 (5.88%) 
Hypermagnesemia   1/78 (1.28%)  0/85 (0.00%) 
Hypernatremia   7/78 (8.97%)  2/85 (2.35%) 
Hypertriglyceridemia   1/78 (1.28%)  0/85 (0.00%) 
Hyperuricemia   0/78 (0.00%)  1/85 (1.18%) 
Hypoalbuminemia   25/78 (32.05%)  19/85 (22.35%) 
Hypocalcemia   21/78 (26.92%)  12/85 (14.12%) 
Hypoglycemia   4/78 (5.13%)  3/85 (3.53%) 
Hypokalemia   31/78 (39.74%)  20/85 (23.53%) 
Hypomagnesemia   42/78 (53.85%)  18/85 (21.18%) 
Hyponatremia   12/78 (15.38%)  18/85 (21.18%) 
Hypophosphatemia   4/78 (5.13%)  2/85 (2.35%) 
Metabolism and nutrition disorders - Other, specify   6/78 (7.69%)  2/85 (2.35%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   6/78 (7.69%)  5/85 (5.88%) 
Arthritis   3/78 (3.85%)  2/85 (2.35%) 
Back pain   23/78 (29.49%)  14/85 (16.47%) 
Bone pain   6/78 (7.69%)  4/85 (4.71%) 
Buttock pain   0/78 (0.00%)  1/85 (1.18%) 
Chest wall pain   6/78 (7.69%)  2/85 (2.35%) 
Flank pain   1/78 (1.28%)  4/85 (4.71%) 
Generalized muscle weakness   6/78 (7.69%)  9/85 (10.59%) 
Joint effusion   1/78 (1.28%)  0/85 (0.00%) 
Joint range of motion decreased   1/78 (1.28%)  1/85 (1.18%) 
Muscle weakness lower limb   4/78 (5.13%)  3/85 (3.53%) 
Muscle weakness upper limb   1/78 (1.28%)  0/85 (0.00%) 
Musculoskeletal and connective tiss disorder - Other   10/78 (12.82%)  15/85 (17.65%) 
Myalgia   8/78 (10.26%)  8/85 (9.41%) 
Myositis   0/78 (0.00%)  1/85 (1.18%) 
Neck pain   7/78 (8.97%)  3/85 (3.53%) 
Osteonecrosis of jaw   1/78 (1.28%)  0/85 (0.00%) 
Osteoporosis   0/78 (0.00%)  1/85 (1.18%) 
Pain in extremity   21/78 (26.92%)  18/85 (21.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other   0/78 (0.00%)  5/85 (5.88%) 
Tumor pain   1/78 (1.28%)  0/85 (0.00%) 
Nervous system disorders     
Amnesia   0/78 (0.00%)  1/85 (1.18%) 
Ataxia   1/78 (1.28%)  0/85 (0.00%) 
Cognitive disturbance   1/78 (1.28%)  1/85 (1.18%) 
Concentration impairment   1/78 (1.28%)  0/85 (0.00%) 
Dizziness   18/78 (23.08%)  13/85 (15.29%) 
Dysgeusia   17/78 (21.79%)  20/85 (23.53%) 
Dysphasia   0/78 (0.00%)  1/85 (1.18%) 
Facial nerve disorder   0/78 (0.00%)  1/85 (1.18%) 
Headache   23/78 (29.49%)  22/85 (25.88%) 
Memory impairment   7/78 (8.97%)  3/85 (3.53%) 
Nervous system disorders-Other   2/78 (2.56%)  0/85 (0.00%) 
Neuralgia   0/78 (0.00%)  1/85 (1.18%) 
Paresthesia   3/78 (3.85%)  3/85 (3.53%) 
Peripheral motor neuropathy   1/78 (1.28%)  2/85 (2.35%) 
Peripheral sensory neuropathy   8/78 (10.26%)  9/85 (10.59%) 
Presyncope   1/78 (1.28%)  0/85 (0.00%) 
Sinus pain   0/78 (0.00%)  3/85 (3.53%) 
Spasticity   1/78 (1.28%)  0/85 (0.00%) 
Tremor   0/78 (0.00%)  2/85 (2.35%) 
Psychiatric disorders     
Agitation   1/78 (1.28%)  0/85 (0.00%) 
Anxiety   14/78 (17.95%)  6/85 (7.06%) 
Confusion   3/78 (3.85%)  5/85 (5.88%) 
Depression   10/78 (12.82%)  4/85 (4.71%) 
Insomnia   13/78 (16.67%)  10/85 (11.76%) 
Libido decreased   1/78 (1.28%)  0/85 (0.00%) 
Psychiatric disorders-Other   0/78 (0.00%)  2/85 (2.35%) 
Restlessness   2/78 (2.56%)  1/85 (1.18%) 
Suicide attempt   1/78 (1.28%)  0/85 (0.00%) 
Renal and urinary disorders     
Acute kidney injury   1/78 (1.28%)  1/85 (1.18%) 
Bladder spasm   1/78 (1.28%)  0/85 (0.00%) 
Chronic kidney disease   2/78 (2.56%)  1/85 (1.18%) 
Cystitis noninfective   0/78 (0.00%)  1/85 (1.18%) 
Hematuria   5/78 (6.41%)  1/85 (1.18%) 
Proteinuria   2/78 (2.56%)  3/85 (3.53%) 
Renal and urinary disorders-Other   4/78 (5.13%)  3/85 (3.53%) 
Renal calculi   1/78 (1.28%)  2/85 (2.35%) 
Renal colic   2/78 (2.56%)  1/85 (1.18%) 
Urinary frequency   3/78 (3.85%)  2/85 (2.35%) 
Urinary tract pain   1/78 (1.28%)  2/85 (2.35%) 
Urinary urgency   2/78 (2.56%)  0/85 (0.00%) 
Reproductive system and breast disorders     
Irregular menstruation   2/78 (2.56%)  0/85 (0.00%) 
Menorrhagia   2/78 (2.56%)  0/85 (0.00%) 
Pelvic pain   1/78 (1.28%)  3/85 (3.53%) 
Reproductive system and breast disorders - Other   1/78 (1.28%)  1/85 (1.18%) 
Vaginal discharge   1/78 (1.28%)  0/85 (0.00%) 
Vaginal dryness   0/78 (0.00%)  2/85 (2.35%) 
Vaginal hemorrhage   1/78 (1.28%)  0/85 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   16/78 (20.51%)  9/85 (10.59%) 
Atelectasis   1/78 (1.28%)  1/85 (1.18%) 
Bronchospasm   0/78 (0.00%)  1/85 (1.18%) 
Cough   36/78 (46.15%)  36/85 (42.35%) 
Dyspnea   26/78 (33.33%)  23/85 (27.06%) 
Epistaxis   22/78 (28.21%)  20/85 (23.53%) 
Hiccups   1/78 (1.28%)  0/85 (0.00%) 
Hoarseness   1/78 (1.28%)  1/85 (1.18%) 
Hypoxia   1/78 (1.28%)  1/85 (1.18%) 
Laryngeal hemorrhage   0/78 (0.00%)  1/85 (1.18%) 
Laryngeal inflammation   0/78 (0.00%)  1/85 (1.18%) 
Nasal congestion   13/78 (16.67%)  8/85 (9.41%) 
Pharyngeal mucositis   3/78 (3.85%)  0/85 (0.00%) 
Pleural effusion   1/78 (1.28%)  0/85 (0.00%) 
Pneumonitis   2/78 (2.56%)  0/85 (0.00%) 
Pneumothorax   1/78 (1.28%)  1/85 (1.18%) 
Postnasal drip   5/78 (6.41%)  6/85 (7.06%) 
Productive cough   8/78 (10.26%)  5/85 (5.88%) 
Resp, thoracic and mediastinal disorders - Other   10/78 (12.82%)  2/85 (2.35%) 
Sinus disorder   2/78 (2.56%)  3/85 (3.53%) 
Sneezing   0/78 (0.00%)  2/85 (2.35%) 
Sore throat   11/78 (14.10%)  12/85 (14.12%) 
Voice alteration   0/78 (0.00%)  1/85 (1.18%) 
Wheezing   8/78 (10.26%)  2/85 (2.35%) 
Skin and subcutaneous tissue disorders     
Alopecia   13/78 (16.67%)  13/85 (15.29%) 
Bullous dermatitis   1/78 (1.28%)  0/85 (0.00%) 
Dry skin   48/78 (61.54%)  37/85 (43.53%) 
Erythema multiforme   3/78 (3.85%)  4/85 (4.71%) 
Hirsutism   8/78 (10.26%)  1/85 (1.18%) 
Hyperhidrosis   2/78 (2.56%)  2/85 (2.35%) 
Hypertrichosis   2/78 (2.56%)  2/85 (2.35%) 
Hypohidrosis   1/78 (1.28%)  0/85 (0.00%) 
Nail discoloration   5/78 (6.41%)  8/85 (9.41%) 
Nail loss   7/78 (8.97%)  6/85 (7.06%) 
Nail ridging   8/78 (10.26%)  10/85 (11.76%) 
Pain of skin   3/78 (3.85%)  1/85 (1.18%) 
Palmar-plantar erythrodysesthesia syndrome   14/78 (17.95%)  9/85 (10.59%) 
Photosensitivity   0/78 (0.00%)  2/85 (2.35%) 
Pruritus   32/78 (41.03%)  26/85 (30.59%) 
Purpura   1/78 (1.28%)  0/85 (0.00%) 
Rash acneiform   62/78 (79.49%)  50/85 (58.82%) 
Rash maculo-papular   36/78 (46.15%)  32/85 (37.65%) 
Scalp pain   1/78 (1.28%)  2/85 (2.35%) 
Skin and subcutaneous tissue disorders - Other   34/78 (43.59%)  21/85 (24.71%) 
Skin hyperpigmentation   1/78 (1.28%)  0/85 (0.00%) 
Skin induration   1/78 (1.28%)  1/85 (1.18%) 
Skin ulceration   1/78 (1.28%)  1/85 (1.18%) 
Urticaria   4/78 (5.13%)  2/85 (2.35%) 
Surgical and medical procedures     
Surgical and medical procedures-Other   3/78 (3.85%)  2/85 (2.35%) 
Vascular disorders     
Flushing   2/78 (2.56%)  1/85 (1.18%) 
Hot flashes   0/78 (0.00%)  1/85 (1.18%) 
Hypertension   19/78 (24.36%)  27/85 (31.76%) 
Hypotension   8/78 (10.26%)  3/85 (3.53%) 
Lymphedema   0/78 (0.00%)  1/85 (1.18%) 
Thromboembolic event   1/78 (1.28%)  3/85 (3.53%) 
Vascular disorders-Other   1/78 (1.28%)  0/85 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lung Committee Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 2066674623
EMail: jmiao@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02438722    
Other Study ID Numbers: S1403
NCI-2014-02405 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BI 1200.124
S1403 ( Other Identifier: SWOG )
S1403 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2015
First Posted: May 8, 2015
Results First Submitted: December 10, 2020
Results First Posted: March 17, 2021
Last Update Posted: March 17, 2021