Trial Outcomes & Findings for Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN (NCT NCT03878979)
NCT ID: NCT03878979
Last Updated: 2024-11-21
Results Overview
Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant)
Results posted on
2024-11-21
Participant Flow
Participant milestones
| Measure |
Newly Diagnosed SCCHN
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
6
|
|
Overall Study
COMPLETED
|
20
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN
Baseline characteristics by cohort
| Measure |
Newly Diagnosed SCCHN
n=20 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=6 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant)Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)
Outcome measures
| Measure |
Newly Diagnosed SCCHN
n=20 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=6 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Safety as Measured by Number of Participants With Drug-related Adverse Events
|
19 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer per participant)Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than \> 28 days from pre-planned day 0.
Outcome measures
| Measure |
Newly Diagnosed SCCHN
n=20 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=6 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Feasibility as Measured by Number of Participants With Successful Completion of Preoperative Treatment and no Extended Treatment-related Delays
|
20 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 0 (Surgery)Number of participants with \< 10% residual tumor in the resection specimen.
Outcome measures
| Measure |
Newly Diagnosed SCCHN
n=19 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=4 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Major Pathologic Response Rate
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsNumber of months until radiologic or clinical progression or death, whichever occurs first.
Outcome measures
| Measure |
Newly Diagnosed SCCHN
n=20 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=6 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
NA months
not estimable due to small number of PFS events
|
23 months
Interval 11.5 to
not estimable due to small number of PFS events
|
SECONDARY outcome
Timeframe: up to 4 weeks after the last dose of nivolumabPopulation: Overall number of participants analyzed for newly diagnosed (15) is different than the number who started in participant flow (20), because 5 patients did not have measurable disease at baseline. Overall number of participants analyzed for recurrence (5) is different than the number who started in participant flow (6), because 1 patient visit was not done.
Number of participants with response as determined by RECIST version 1.1 and immune-related response criteria (irRC). Per RECIST criteria, Complete response (CR) is a disappearance of all target lesions, Partial response (PR) is \>= 30% decrease in the sum of the largest diameter (LD) of target lesions, Progressive disease (PD) is \>= 20% increase in the sum of the LD of target lesions. Per irRC, immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a 25% increase in tumour burden from the lowest level recorded.
Outcome measures
| Measure |
Newly Diagnosed SCCHN
n=15 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=5 Participants
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Radiographic Response Rate
Progressive Disease (PD)
|
4 Participants
|
2 Participants
|
|
Radiographic Response Rate
Not evaluable
|
1 Participants
|
0 Participants
|
|
Radiographic Response Rate
Partial Response (PR)
|
1 Participants
|
1 Participants
|
|
Radiographic Response Rate
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
Radiographic Response Rate
Stable Disease (SD)
|
9 Participants
|
2 Participants
|
Adverse Events
Newly Diagnosed SCCHN
Serious events: 5 serious events
Other events: 20 other events
Deaths: 4 deaths
Reccurence of SCCHN
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Newly Diagnosed SCCHN
n=20 participants at risk
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=6 participants at risk
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Cardiac disorders
Cardiac ischemia
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Immune system disorders
Fever
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Blood and lymphatic system disorders
Left arm edema
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
Other adverse events
| Measure |
Newly Diagnosed SCCHN
n=20 participants at risk
One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
Reccurence of SCCHN
n=6 participants at risk
One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.
Nivolumab 480mg and surgical resection: One dose of Nivolumab 480mg given four weeks prior to surgical resection.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Abrasion on chin
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Achy bilateral leg muscles
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Cardiac disorders
Anemia
|
20.0%
4/20 • Number of events 4 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Psychiatric disorders
Anorexia
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Bilateral hand tremor
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral shoulder pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-other
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Bruising left hand
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Immune system disorders
Chronic arthritis
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Psychiatric disorders
Concentration impairment with increase in gabapentin
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Coughing in morning
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Decreased absolute lymphocyte count
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
33.3%
2/6 • Number of events 2 • approximately 3 years 3 months
|
|
Investigations
Decreased lymphocyte count
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Decreased mean platelet volume
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Decreased range of motion - neck
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Surgical and medical procedures
Distal tip of incision has necrosis
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Dysphagia
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Investigations
Elevated alanine aminotransferase
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Elevated alk
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Elevated alkaline phosphatase
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Elevated alt
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Elevated aspartate aminotransferase
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Endocrine disorders
Elevated tsh
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Eye disorders
Eyelid-drooping
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Facial edema (right side)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Facial pain
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Facial pain (left jaw) worsening
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Facial pain (right side jaw)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Fatigue
|
20.0%
4/20 • Number of events 4 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
General disorders
Fever of 101.5 f
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Eye disorders
Floaters right eye
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Forgetfulness
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Gait imbalance
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Generalized dry skin
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle aches
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Halitosis
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Headache
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
General disorders
Headache (consistent)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Headache behind both eyes
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Headache in back of eye going to back of head
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Eye disorders
Hematoma in left eye
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Cardiac disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Increased fatigue
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Increased pain and swelling of gums and mouth
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Increased pain with swallowing
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza b infection
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Intermittent dizziness
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
General disorders
Intermittent facial pain (right side jaw)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent sternal pain (deep inspiration)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Renal and urinary disorders
Intermittent urinary incontinence
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Jaw pain (facial pain)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Left arm bruise
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Ear and labyrinth disorders
Left ear pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Left face & neck pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Left lower back pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Left peri-oral numbness
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Immune system disorders
Leukocytosis
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Light headedness
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Eye disorders
Light sensitivity
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
33.3%
2/6 • Number of events 2 • approximately 3 years 3 months
|
|
Investigations
Lymphocytes absolute decreased
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash - (chest)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash-lower back
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Malaise
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Memory impairment with increase in gabapentin
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Psychiatric disorders
Mild depression
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
General disorders
Mild nausea
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Mild shortness of breath (stair climbing)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Mild swelling in the area of tumor
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 3 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Surgical and medical procedures
Necrosis & dehiscence
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Numbness - thumb and first 2 fingers
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Numbness (right side face)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Numbness in left neck area
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Numbness/left side of face
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Occasional cough
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Occasional diarrhea following laxative use
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Occasional lower back pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Occasional mild nausea
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Occasional nausea
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Oral mucositis
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
4/20 • Number of events 4 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain bi-lateral forearm
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Paresthesia on left side face
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Paresthesia (left ear)
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Nervous system disorders
Paresthesia (numbness in fingertips bilaterally)
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
General disorders
Pedal edema
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia (lung infection)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Surgical and medical procedures
Post-surgical mouth pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Surgical and medical procedures
Post-surgical neck pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Number of events 3 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
15.0%
3/20 • Number of events 3 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Reflux
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Ear and labyrinth disorders
Right sided ear pain
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Right sided headache
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Ear and labyrinth disorders
Significant pain in right ear
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Skin infection (left great toe cellulitis)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Skin and subcutaneous tissue disorders
Small reddened area- right upper arm
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.0%
3/20 • Number of events 3 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Soreness in left neck
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Syncope (during blood draw)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Eye disorders
Visual changes in left eye
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Voice changes (hoarseness)
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
General disorders
Weight loss
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Worsening constipation
|
5.0%
1/20 • Number of events 1 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Nervous system disorders
Worsening fatigue
|
10.0%
2/20 • Number of events 2 • approximately 3 years 3 months
|
0.00%
0/6 • approximately 3 years 3 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
|
Gastrointestinal disorders
Oral pain (tongue)
|
0.00%
0/20 • approximately 3 years 3 months
|
16.7%
1/6 • Number of events 1 • approximately 3 years 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place