Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer (NCT NCT03521570)
NCT ID: NCT03521570
Last Updated: 2024-09-19
Results Overview
95% confidence interval will be estimated by Kaplan-Meier method for all participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
1 year from study start
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Treatment (Nivolumab, IMRT)
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Treatment (Nivolumab, IMRT)
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Overall Study
Not eligible
|
11
|
Baseline Characteristics
Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year from study start95% confidence interval will be estimated by Kaplan-Meier method for all participants.
Outcome measures
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Number of Participants With Progression-Free Survival (PFS)
|
27 Participants
|
SECONDARY outcome
Timeframe: 1 year from study startWill be assessed using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Number of Participants With Overall Survival (OS)
|
84.4 percentage of participants
Interval 74.4 to 95.7
|
SECONDARY outcome
Timeframe: 1 year from study startTo evaluate patterns of failure as local, regional, or distant.
Outcome measures
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Number of Participants With Pattern of Failure
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year from study startAcute toxicities will be identified and their incidence rate estimated.
Outcome measures
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Number of Participants With Incidence of Acute Adverse Events
fatigue
|
82.4 percentage of participants
|
|
Number of Participants With Incidence of Acute Adverse Events
dermatitis
|
58.8 percentage of participants
|
|
Number of Participants With Incidence of Acute Adverse Events
dysphagia
|
54.9 percentage of participants
|
|
Number of Participants With Incidence of Acute Adverse Events
mucositis
|
49 percentage of participants
|
|
Number of Participants With Incidence of Acute Adverse Events
dry mouth
|
47.1 percentage of participants
|
|
Number of Participants With Incidence of Acute Adverse Events
Lymphopenia
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 years from study startLate toxicities will be identified and their incidence rate estimated.
Outcome measures
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Number of Participants With Incidence of Late Adverse Events
|
3 Participants
|
SECONDARY outcome
Timeframe: At baseline, end of Intensity-Modulated Radiation Therapy, and weeks 18, 30, 52, and 104, baseline and month 12The FACT-HN (Functional Assessment of Cancer Therapy-Head and Neck) (version 4) consists of a cancer-specific questionnaire, FACT-G (Functional Assessment of Cancer Therapy - General), in addition to 12 H\&N cancer-specific items (the HN subscale).The Functional Assessment of Cancer Therapy-Head and Neck Quality of Life questionnaire may be completed by the patient using paper or electronically. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL
Outcome measures
| Measure |
Treatment (Nivolumab, IMRT)
n=51 Participants
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Quality of Life (QOL)
Baseline
|
68 score on a scale
Standard Deviation 89.2
|
|
Quality of Life (QOL)
End of IMRT
|
62.5 score on a scale
Standard Deviation 90
|
|
Quality of Life (QOL)
Week 18
|
62 score on a scale
Standard Deviation 93.4
|
|
Quality of Life (QOL)
Week 30
|
74.6 score on a scale
Standard Deviation 101
|
|
Quality of Life (QOL)
Week 52
|
59 score on a scale
Standard Deviation 94.5
|
|
Quality of Life (QOL)
Week 104
|
59 score on a scale
Standard Deviation 94.5
|
Adverse Events
Treatment (Nivolumab, IMRT)
Serious events: 24 serious events
Other events: 51 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab, IMRT)
n=51 participants at risk
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
General disorders
Death
|
47.1%
24/51 • 2 years
|
Other adverse events
| Measure |
Treatment (Nivolumab, IMRT)
n=51 participants at risk
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
IMRT: Undergo intensity-modulated radiation therapy
Nivolumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Oral pain
|
23.5%
12/51 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
47.1%
24/51 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
17/51 • 2 years
|
|
Psychiatric disorders
Agitation
|
5.9%
3/51 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
54.9%
28/51 • 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
58.8%
30/51 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
39.2%
20/51 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
37.3%
19/51 • 2 years
|
|
General disorders
Fatigue
|
78.4%
40/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
4/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
3/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
9/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
3/51 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
3.9%
2/51 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
47.1%
24/51 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.9%
2/51 • 2 years
|
|
Psychiatric disorders
Anxiety
|
23.5%
12/51 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.5%
12/51 • 2 years
|
|
Psychiatric disorders
Insomnia
|
15.7%
8/51 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
9/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.9%
28/51 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
41.2%
21/51 • 2 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
3/51 • 2 years
|
|
General disorders
Chills
|
7.8%
4/51 • 2 years
|
|
General disorders
Oral dysesthesia
|
2.0%
1/51 • 2 years
|
|
Investigations
Weight loss
|
21.6%
11/51 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
21.6%
11/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
19.6%
10/51 • 2 years
|
|
Psychiatric disorders
Depression
|
19.6%
10/51 • 2 years
|
|
Investigations
Creatinine increased
|
9.8%
5/51 • 2 years
|
|
General disorders
Pain
|
21.6%
11/51 • 2 years
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
2.0%
1/51 • 2 years
|
|
Nervous system disorders
Dysesthesia
|
3.9%
2/51 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
17/51 • 2 years
|
|
General disorders
Esophageal pain
|
2.0%
1/51 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
25.5%
13/51 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
4/51 • 2 years
|
|
Infections and infestations
Bronchial infection
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Lung infection
|
5.9%
3/51 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.9%
3/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
15.7%
8/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
3.9%
2/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
6/51 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
27.5%
14/51 • 2 years
|
|
Vascular disorders
Lymphedema
|
9.8%
5/51 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
5.9%
3/51 • 2 years
|
|
Infections and infestations
Mucosal infection
|
3.9%
2/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.8%
5/51 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
2/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
13.7%
7/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
3.9%
2/51 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
21.6%
11/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
4/51 • 2 years
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/51 • 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
17.6%
9/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.8%
5/51 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
3.9%
2/51 • 2 years
|
|
Nervous system disorders
Paresthesia
|
13.7%
7/51 • 2 years
|
|
Nervous system disorders
Headache
|
13.7%
7/51 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.9%
3/51 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
6/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
23.5%
12/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
11.8%
6/51 • 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.9%
3/51 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
3.9%
2/51 • 2 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
3.9%
2/51 • 2 years
|
|
Eye disorders
Eye pain
|
3.9%
2/51 • 2 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.0%
1/51 • 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
9.8%
5/51 • 2 years
|
|
General disorders
Facial pain
|
5.9%
3/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.7%
7/51 • 2 years
|
|
Nervous system disorders
Facial nerve disorder
|
2.0%
1/51 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.9%
2/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.9%
2/51 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.0%
1/51 • 2 years
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.8%
6/51 • 2 years
|
|
Infections and infestations
Infective myositis
|
2.0%
1/51 • 2 years
|
|
Nervous system disorders
Myasthenia gravis
|
2.0%
1/51 • 2 years
|
|
Investigations
White blood cell decreased
|
5.9%
3/51 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
3/51 • 2 years
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/51 • 2 years
|
|
Investigations
Investigations - Other, specify
|
2.0%
1/51 • 2 years
|
|
Eye disorders
Eyelid function disorder
|
2.0%
1/51 • 2 years
|
|
General disorders
Edema face
|
7.8%
4/51 • 2 years
|
|
Nervous system disorders
Dysphasia
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Sinusitis
|
5.9%
3/51 • 2 years
|
|
Cardiac disorders
Heart failure
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.9%
2/51 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
3.9%
2/51 • 2 years
|
|
Nervous system disorders
Tremor
|
2.0%
1/51 • 2 years
|
|
Vascular disorders
Hypotension
|
3.9%
2/51 • 2 years
|
|
Investigations
Weight gain
|
3.9%
2/51 • 2 years
|
|
Investigations
Platelet count decreased
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
4/51 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.8%
5/51 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.9%
2/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.8%
4/51 • 2 years
|
|
General disorders
Neck edema
|
7.8%
4/51 • 2 years
|
|
Eye disorders
Cataract
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/51 • 2 years
|
|
Renal and urinary disorders
Renal calculi
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Wound infection
|
2.0%
1/51 • 2 years
|
|
General disorders
Flu like symptoms
|
3.9%
2/51 • 2 years
|
|
Infections and infestations
Conjunctivitis
|
2.0%
1/51 • 2 years
|
|
Investigations
Cardiac troponin I increased
|
2.0%
1/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.9%
3/51 • 2 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
9.8%
5/51 • 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
9.8%
5/51 • 2 years
|
|
Nervous system disorders
Dizziness
|
17.6%
9/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.7%
8/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
4/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.8%
6/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
2.0%
1/51 • 2 years
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • 2 years
|
|
Nervous system disorders
Hypersomnia
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
2/51 • 2 years
|
|
Eye disorders
Floaters
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
5/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
3.9%
2/51 • 2 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.9%
2/51 • 2 years
|
|
General disorders
Fever
|
7.8%
4/51 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
3/51 • 2 years
|
|
General disorders
Localized edema
|
2.0%
1/51 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.9%
2/51 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Stoma site infection
|
3.9%
2/51 • 2 years
|
|
Infections and infestations
Tracheitis
|
2.0%
1/51 • 2 years
|
|
Nervous system disorders
Dysarthria
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
3.9%
2/51 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
3.9%
2/51 • 2 years
|
|
General disorders
Malaise
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Thrush
|
2.0%
1/51 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.9%
2/51 • 2 years
|
|
General disorders
Edema limbs
|
2.0%
1/51 • 2 years
|
|
Immune system disorders
Anaphylaxis
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Skin infection
|
2.0%
1/51 • 2 years
|
|
Metabolism and nutrition disorders
Obesity
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
2.0%
1/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.9%
2/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.0%
1/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/51 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Sepsis
|
2.0%
1/51 • 2 years
|
|
Eye disorders
Blurred vision
|
3.9%
2/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Gastroparesis
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/51 • 2 years
|
|
Injury, poisoning and procedural complications
Stomal ulcer
|
2.0%
1/51 • 2 years
|
|
Cardiac disorders
Palpitations
|
2.0%
1/51 • 2 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.0%
1/51 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
1/51 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.0%
1/51 • 2 years
|
|
Vascular disorders
Flushing
|
3.9%
2/51 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/51 • 2 years
|
|
Infections and infestations
Meningitis
|
2.0%
1/51 • 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.0%
1/51 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/51 • 2 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.0%
1/51 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place