Trial Outcomes & Findings for Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck (NCT NCT01979211)
NCT ID: NCT01979211
Last Updated: 2024-02-29
Results Overview
The primary endpoint of this study was 2-year locoregional control (LRC), defined as no evidence of recurrent cancer in the tumor bed and/or neck as assessed via clinical exam and imaging. Locoregional control was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who had LRC) and the time for them to be censored.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
2 years
Results posted on
2024-02-29
Participant Flow
Participant milestones
| Measure |
Cetuximab and Radiation
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Cetuximab and Radiation
n=24 Participants
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 24 data points were included in the Kaplan-Meier method and yielded an predicted percentage of individuals with LRC at a 2 year mark. Analysis yielded a predicted 91% of subjects had LRC. Extrapolating this percentage to the overall number of participants analyzed, 21.84 subjects had LRC.
The primary endpoint of this study was 2-year locoregional control (LRC), defined as no evidence of recurrent cancer in the tumor bed and/or neck as assessed via clinical exam and imaging. Locoregional control was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who had LRC) and the time for them to be censored.
Outcome measures
| Measure |
Cetuximab and Radiation
n=24 Participants
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Percentage of Participants With Local Regional Control
|
91.1 percentage of subjects
Interval 80.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 24 data points were included in the Kaplan-Meier method and yielded an predicted percentage of individuals with DFS at a 2 year mark. Analysis predicted 70.8% of subjects were alive with no disease. Extrapolating this percentage to the overall number of participants analyzed, 16.99 subjects were alive with no disease.
The primary endpoint of this study was 2-year disease-free survival (DFS), which was the absence of locoregional recurrence or metastatic disease (biopsied when possible). DFS was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who were alive disease-free) and the time for them to be censored.
Outcome measures
| Measure |
Cetuximab and Radiation
n=24 Participants
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Percentage of Participants With Disease-free Survival
|
70.8 percentage of participants
Interval 54.8 to 91.6
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 24 data points were included in the Kaplan-Meier method and yielded an predicted percentage of individuals with OS at a 5 year mark. Analysis predicted 56.1% of subjects were alive. Extrapolating this percentage to the overall number of participants analyzed, 13.34 subjects were alive at the 5 year mark.
The primary endpoint of this study was 5-year overall survival (OS), defined as the absence of death from any cause during those respective time periods. OS was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who were alive) and the time for them to be censored.
Outcome measures
| Measure |
Cetuximab and Radiation
n=24 Participants
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Percentage of Participants With Overall Survival
|
56.1 percentage of participants
Interval 38.7 to 81.3
|
Adverse Events
Cetuximab and Radiation
Serious events: 3 serious events
Other events: 24 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Cetuximab and Radiation
n=24 participants at risk
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Lip pain
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
Other adverse events
| Measure |
Cetuximab and Radiation
n=24 participants at risk
Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Cetuximab: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation Therapy: Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
2/24 • Number of events 9 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Investigations
Alkaline phosphatase increased
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Immune system disorders
Allergic reaction
|
4.2%
1/24 • Number of events 2 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Number of events 4 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.8%
5/24 • Number of events 28 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Eye disorders
Blurred vision
|
4.2%
1/24 • Number of events 11 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
General disorders
Chills
|
4.2%
1/24 • Number of events 2 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Number of events 6 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
3/24 • Number of events 14 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 12 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Investigations
Creatinine increased
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • Number of events 2 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
25.0%
6/24 • Number of events 34 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • Number of events 4 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Dry mouth
|
20.8%
5/24 • Number of events 21 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • Number of events 21 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Nervous system disorders
Dysgeusia
|
29.2%
7/24 • Number of events 40 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Number of events 4 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Eye disorders
Eye disorders - Other, specify
|
8.3%
2/24 • Number of events 21 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Eye disorders
Eye infection
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Eye disorders
Eye pain
|
4.2%
1/24 • Number of events 12 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Nervous system disorders
Facial nerve disorder
|
4.2%
1/24 • Number of events 11 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
General disorders
Facial pain
|
12.5%
3/24 • Number of events 5 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
General disorders
Fatigue
|
58.3%
14/24 • Number of events 91 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
General disorders
Fever
|
4.2%
1/24 • Number of events 2 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 23 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
1/24 • Number of events 6 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
2/24 • Number of events 27 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
3/24 • Number of events 7 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Investigations
Infections and infestations - Other, specify
|
8.3%
2/24 • Number of events 14 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
General disorders
Infusion related reaction
|
4.2%
1/24 • Number of events 7 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Mucositis oral
|
54.2%
13/24 • Number of events 81 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
1/24 • Number of events 13 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
6/24 • Number of events 28 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 4 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
4.2%
1/24 • Number of events 12 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
3/24 • Number of events 18 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
General disorders
Pain
|
8.3%
2/24 • Number of events 13 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Infections and infestations
Pharyngitis
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Number of events 18 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
91.7%
22/24 • Number of events 177 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
8.3%
2/24 • Number of events 7 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
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Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
4/24 • Number of events 21 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Vascular disorders
Thromboembolic event
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
4.2%
1/24 • Number of events 13 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.2%
1/24 • Number of events 3 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Infections and infestations
Upper respiratory infection
|
4.2%
1/24 • Number of events 1 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
4.2%
1/24 • Number of events 6 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
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Investigations
Weight loss
|
4.2%
1/24 • Number of events 9 • All-Cause Mortality was followed up to 5 years after the start of treatment. Serious Adverse Events and Other (Not Including Serious) Adverse Events were followed up to 24 months after the start of treatment.
The definition does not differ from clinicialtrials.gov's definitions.
|
Additional Information
Vinita Takiar, Associate Professor, MD
University of Cincinnati Cancer Center
Phone: 513-584-4775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place