Trial Outcomes & Findings for Inhibition of Oral Tumorigenesis by Antitumor B (NCT NCT04278989)
NCT ID: NCT04278989
Last Updated: 2026-03-25
Results Overview
This measure is the immunohistochemical evaluation using the antihuman Ki-67 monoclonal antibody MIB-1 and reporting the percentage of positively stained malignant cells.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Baseline and after surgery (seven to 28 days after baseline)
Results posted on
2026-03-25
Participant Flow
This began as a randomized study with a parallel design. Part way through it, the investigator decided to make it an open label, single arm study that would just recruit subjects taking ATB. The control group represents seven placebo subjects and seven samples taken from the local tissue bank.
Participant milestones
| Measure |
Anti-tumor B
1,200 mg three times a day.
Anti-tumor B: 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
|
Untreated Control
This group received no treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Anti-tumor B
1,200 mg three times a day.
Anti-tumor B: 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
|
Untreated Control
This group received no treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Inhibition of Oral Tumorigenesis by Antitumor B
Baseline characteristics by cohort
| Measure |
Anti-tumor B
n=16 Participants
1,200 mg three times a day.
Anti-tumor B: 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
|
Untreated
n=7 Participants
These subjects received no treatment.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
10 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=138 Participants
|
4 Participants
n=62 Participants
|
13 Participants
n=123 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=138 Participants
|
5 Participants
n=62 Participants
|
17 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
20 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
19 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=138 Participants
|
7 participants
n=62 Participants
|
23 participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline and after surgery (seven to 28 days after baseline)Population: Sixteen subjects received ATB, however, one subject had only one dose and was removed for analysis. The control group consisted of seven subjects who received placebos and seven matched controls.
This measure is the immunohistochemical evaluation using the antihuman Ki-67 monoclonal antibody MIB-1 and reporting the percentage of positively stained malignant cells.
Outcome measures
| Measure |
Anti-tumor B
n=15 Participants
1,200 mg three times a day.
Anti-tumor B: 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
|
No Treatment
n=14 Participants
This is the control group that had no treatment.
|
|---|---|---|
|
Percent of Ki-67 Positive Cells
Baseline, Ki-67 staining proportion
|
.4023 percentage of stained tumor cell nuclei
Standard Deviation .1266
|
.5872 percentage of stained tumor cell nuclei
Standard Deviation 1316
|
|
Percent of Ki-67 Positive Cells
Post surgery, Ki-67 staining proportion
|
.3732 percentage of stained tumor cell nuclei
Standard Deviation .1249
|
.5035 percentage of stained tumor cell nuclei
Standard Deviation 1336
|
Adverse Events
Anti-tumor B
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Untreated Group
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-tumor B
n=16 participants at risk
1,200 mg three times a day.
Anti-tumor B: 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
|
Untreated Group
n=7 participants at risk
This group received no treatment.
|
|---|---|---|
|
Infections and infestations
Neck abscess
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Infections and infestations
Pleural infection
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
Other adverse events
| Measure |
Anti-tumor B
n=16 participants at risk
1,200 mg three times a day.
Anti-tumor B: 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
|
Untreated Group
n=7 participants at risk
This group received no treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.2%
5/16 • Number of events 9 • Up to six weeks.
|
57.1%
4/7 • Number of events 5 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
42.9%
3/7 • Number of events 3 • Up to six weeks.
|
|
Psychiatric disorders
Anxiety
|
18.8%
3/16 • Number of events 3 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Belching
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Investigations
Cholesterol high
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • Number of events 3 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
42.9%
3/7 • Number of events 4 • Up to six weeks.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 3 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
28.6%
2/7 • Number of events 2 • Up to six weeks.
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
31.2%
5/16 • Number of events 6 • Up to six weeks.
|
57.1%
4/7 • Number of events 5 • Up to six weeks.
|
|
Ear and labyrinth disorders
Ear pain
|
18.8%
3/16 • Number of events 3 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
42.9%
3/7 • Number of events 3 • Up to six weeks.
|
|
Eye disorders
corneal abrasion
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
42.9%
3/7 • Number of events 3 • Up to six weeks.
|
|
General disorders
Fever
|
18.8%
3/16 • Number of events 3 • Up to six weeks.
|
28.6%
2/7 • Number of events 4 • Up to six weeks.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Oral sensitivity
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Gingiva sores
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Psychiatric disorders
Hallucinations
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Vascular disorders
Hot flashes
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
42.9%
3/7 • Number of events 4 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Vascular disorders
Hypertension
|
18.8%
3/16 • Number of events 5 • Up to six weeks.
|
71.4%
5/7 • Number of events 6 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 2 • Up to six weeks.
|
28.6%
2/7 • Number of events 4 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
42.9%
3/7 • Number of events 3 • Up to six weeks.
|
|
Vascular disorders
Hypotension
|
31.2%
5/16 • Number of events 5 • Up to six weeks.
|
28.6%
2/7 • Number of events 2 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
28.6%
2/7 • Number of events 2 • Up to six weeks.
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Number of events 5 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary nodule
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Oral pain
|
43.8%
7/16 • Number of events 9 • Up to six weeks.
|
57.1%
4/7 • Number of events 6 • Up to six weeks.
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Nervous system disorders
Paresthesia
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
28.6%
2/7 • Number of events 2 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus tachycardia
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
42.9%
3/7 • Number of events 3 • Up to six weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Number of events 2 • Up to six weeks.
|
28.6%
2/7 • Number of events 2 • Up to six weeks.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Eye disorders
Vision decreased
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
5/16 • Number of events 5 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Investigations
weight gain
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Investigations
Weight loss
|
25.0%
4/16 • Number of events 5 • Up to six weeks.
|
0.00%
0/7 • Up to six weeks.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.2%
1/16 • Number of events 1 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Injury, poisoning and procedural complications
Wound infection
|
25.0%
4/16 • Number of events 4 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
General disorders
Edema face
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
General disorders
Facial pain
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Gastrointestinal disorders
Thick secretions
|
0.00%
0/16 • Up to six weeks.
|
28.6%
2/7 • Number of events 2 • Up to six weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
General disorders
Malaise
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
General disorders
Neck edema
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Infections and infestations
Thrush
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 1 • Up to six weeks.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/16 • Up to six weeks.
|
14.3%
1/7 • Number of events 3 • Up to six weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place