Trial Outcomes & Findings for Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy (NCT NCT03355560)
NCT ID: NCT03355560
Last Updated: 2026-05-06
Results Overview
As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Results posted on
2026-05-06
Participant Flow
Participant milestones
| Measure |
Nivolumab
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab: Nivolumab 480 mg IV infusion
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Baseline characteristics by cohort
| Measure |
Nivolumab
n=39 Participants
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab: Nivolumab 480 mg IV infusion
|
|---|---|
|
Age, Continuous
|
68 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=54 Participants
|
|
>10 pack year tobacco smoking history
|
24 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.
Outcome measures
| Measure |
Nivolumab
n=39 Participants
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab: Nivolumab 480 mg IV infusion
|
|---|---|
|
Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab
|
17 Participants
|
SECONDARY outcome
Timeframe: AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one adverse while on treatment of nivolumab for a minimum of 30 days following the last dose of study treatment. Adverse Events were not collected beyond the 30 days following the last dose.
Outcome measures
| Measure |
Nivolumab
n=39 Participants
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab: Nivolumab 480 mg IV infusion
|
|---|---|
|
Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab
|
37 Participants
|
SECONDARY outcome
Timeframe: Median follow up was 22.1 monthsThe primary endpoint of this study was disease free survival (DFS) at 2-years as measured from the time of treatment allocation to the first evidence of any tumor or death from any cause. The "median follow-up of 22.1 months" reflects the actual duration of follow-up across participants at the time of data analysis. While the outcome measure was designed to be assessed at the 2-year mark, not all participants had reached exactly 24 months of follow-up when the data were analyzed. Therefore, the median follow-up time represents the central tendency of the follow-up duration for the cohort.
Outcome measures
| Measure |
Nivolumab
n=39 Participants
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab: Nivolumab 480 mg IV infusion
|
|---|---|
|
Disease Free Survival
|
71.4 percentage of participants
Interval 57.8 to 88.1
|
SECONDARY outcome
Timeframe: 2 yearPopulation: 2-year DFS measured per-protocol from date of first nivolumab treatment
Outcome measures
| Measure |
Nivolumab
n=39 Participants
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab: Nivolumab 480 mg IV infusion
|
|---|---|
|
Disease Free Survival
|
71.37 Percentage of subjects
Interval 57.8 to 88.8
|
Adverse Events
Nivolumab
Serious events: 9 serious events
Other events: 37 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Nivolumab
n=39 participants at risk
Nivolumab starting 4-11 weeks after surgery for 6 doses.
|
|---|---|
|
Nervous system disorders
Encephalopathy
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Abdominal wall cellulitis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Bone infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Soft tissue infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
Other adverse events
| Measure |
Nivolumab
n=39 participants at risk
Nivolumab starting 4-11 weeks after surgery for 6 doses.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Metabolism and nutrition disorders
Anorexia
|
15.4%
6/39 • Number of events 6 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Psychiatric disorders
Anxiety
|
10.3%
4/39 • Number of events 4 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.8%
5/39 • Number of events 6 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Baker's cyst
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Blisters on arm
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Bloody drainage at PEG site
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Bruising
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Candidiasis around PEG tube insertion site
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Chills
|
7.7%
3/39 • Number of events 3 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Clogged feeding tube
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Colonic diverticulitis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Eye disorders
Conjunctivitis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Constipation
|
12.8%
5/39 • Number of events 5 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
7/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Investigations
Creatinine increased
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breath sounds
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Psychiatric disorders
Depression
|
7.7%
3/39 • Number of events 3 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Device related infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
7/39 • Number of events 8 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Psychiatric disorders
Difficulty waking from strange dreams
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Dislodged hearing tube
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Dizziness
|
12.8%
5/39 • Number of events 6 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Drooling
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
4/39 • Number of events 5 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
3/39 • Number of events 3 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Dysarthria
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Dysgeusia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Dysphagia
|
15.4%
6/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
6/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Renal and urinary disorders
Dysuria
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Renal and urinary disorders
Dysurua
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Ear and labyrinth disorders
Ear pain
|
10.3%
4/39 • Number of events 5 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Edema Face
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Edema face
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Edema limbs
|
7.7%
3/39 • Number of events 3 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Reproductive system and breast disorders
Epididymla orchitis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Erythematous patch
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Facial pain
|
10.3%
4/39 • Number of events 4 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Fatigue
|
35.9%
14/39 • Number of events 15 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Fever
|
12.8%
5/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Flu like symptoms
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Vascular disorders
Flushing
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Generalized edema
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Generalized itching
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Granuloma at flap
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Hair growth from flap
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Headache
|
12.8%
5/39 • Number of events 5 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Hyperphagia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Endocrine disorders
Hypothyroidism
|
12.8%
5/39 • Number of events 5 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Surgical and medical procedures
Hypoxia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Investigations
Increased BUN
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Investigations
Increased ESR, CRP
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Increased mucus at trach stoma
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Inflammed and bumpy on lips
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.6%
1/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Psychiatric disorders
Irritibility
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Lethargy
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Localized edema
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Vascular disorders
Lymphedema
|
7.7%
3/39 • Number of events 4 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Malaise
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Mucositis oral
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Nausea
|
12.8%
5/39 • Number of events 5 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Neck and shoulder stiffness
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Neck edema
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.3%
4/39 • Number of events 4 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Renal and urinary disorders
Nocturia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Odynophagia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Oral Pain
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Oral pain
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Oral secretions
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
2.6%
1/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
PEG pulled out
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Pain
|
15.4%
6/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
2/39 • Number of events 4 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Paresthesia
|
15.4%
6/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Pharyngeal wall black
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
General disorders
Pharyngeal wall edema
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pre-malignant lesion
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Pressure injury
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
3/39 • Number of events 3 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
6/39 • Number of events 6 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
3/39 • Number of events 3 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Rash on back
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Salivary bypass tube migrated
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Cardiac disorders
Sinus Tachycardia
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.8%
5/39 • Number of events 6 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Stroke
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Cardiac disorders
Systolic murmur
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
TEP complication
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
TEP prosthesis leaking
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
TEP prothesis fell out, TE puncuture closed
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
TEP pulled through anterior mucosal tissue
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Tooth infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal hemorrhage
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Nervous system disorders
Tremor
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Trismus
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Upper Respiratory Infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Renal and urinary disorders
Urinary frequency
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Investigations
Weight gain
|
17.9%
7/39 • Number of events 7 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Investigations
Weight loss
|
23.1%
9/39 • Number of events 9 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.1%
2/39 • Number of events 2 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Wound infection
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
|
Infections and infestations
Yellow thick secretions from fistula
|
2.6%
1/39 • Number of events 1 • AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
|
Additional Information
Trisha Wise-Draper M.D., Ph.D.
University of Cincinnati Cancer Center
Phone: (513) 558-2826
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place