Trial Outcomes & Findings for Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma (NCT NCT04869137)
NCT ID: NCT04869137
Last Updated: 2026-04-08
Results Overview
Pathological Complete Response will be determined by pathologist examination of tissue after neoadjuvant treatment and resection
ACTIVE_NOT_RECRUITING
PHASE2
26 participants
1 year
2026-04-08
Participant Flow
Participant milestones
| Measure |
Lenvatinib Plus Pembrolizumab
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Lenvatinib Plus Pembrolizumab
n=26 Participants
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Age, Continuous
|
69 years
n=527 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=527 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=527 Participants
|
PRIMARY outcome
Timeframe: 1 yearPathological Complete Response will be determined by pathologist examination of tissue after neoadjuvant treatment and resection
Outcome measures
| Measure |
Lenvatinib Plus Pembrolizumab
n=26 Participants
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Pathological Complete Response
|
57.7 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearProgressive disease will be defined by the detection of any recurrent disease following complete surgical resection or by progression of disease that is not amenable to complete surgical resection prior to planned surgery.
Outcome measures
| Measure |
Lenvatinib Plus Pembrolizumab
n=26 Participants
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Progression Free Survival
|
NA Months
Interval 21.4 to
not enough events to reach the median or upper limit of 95% confidence interval
|
SECONDARY outcome
Timeframe: Assessed up to completion of planned surgical resection, up to 10 weeksFeasibility of treatment will be defined by the percentage of patients able to complete both neoadjuvant cycles of trial therapy and be able to complete surgical resection as planned.
Outcome measures
| Measure |
Lenvatinib Plus Pembrolizumab
n=26 Participants
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Percentage of Patients Able to Complete Both Neoadjuvant Cycles of Trial Therapy and Able to Complete Planned Surgical Resection.
|
92.3 percentage of participants
|
Adverse Events
Lenvatinib Plus Pembrolizumab
Serious adverse events
| Measure |
Lenvatinib Plus Pembrolizumab
n=26 participants at risk
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
General disorders
Death NOS
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
General disorders
Sudden death NOS
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung infection
|
3.8%
1/26 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Lenvatinib Plus Pembrolizumab
n=26 participants at risk
Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.
Lenvatinib Oral Product: 20mg of Lenvatinib will be taken orally once daily
Pembrolizumab: 200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
|
|---|---|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Eye disorders
Eye disorders - Other, specify
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Eye disorders
Blurred vision
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Eye disorders
Dry eye
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Eye disorders
Glaucoma
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Eye disorders
Uveitis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Eye disorders
Vision decreased
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Cardiac disorders
Chest pain - cardiac
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
2/26 • Number of events 8 • 1 year
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Immune system disorders
Allergic reaction
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.4%
4/26 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.5%
3/26 • Number of events 8 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
42.3%
11/26 • Number of events 18 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
34.6%
9/26 • Number of events 14 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
23.1%
6/26 • Number of events 7 • 1 year
|
|
Investigations
Platelet count decreased
|
19.2%
5/26 • Number of events 5 • 1 year
|
|
Investigations
Weight loss
|
19.2%
5/26 • Number of events 5 • 1 year
|
|
Investigations
Creatinine increased
|
15.4%
4/26 • Number of events 7 • 1 year
|
|
Investigations
Thyroid stimulating hormone increased
|
15.4%
4/26 • Number of events 4 • 1 year
|
|
Investigations
Hemoglobin increased
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Investigations
Investigations - Other, specify
|
7.7%
2/26 • Number of events 6 • 1 year
|
|
Investigations
White blood cell decreased
|
7.7%
2/26 • Number of events 3 • 1 year
|
|
Investigations
Blood bilirubin increased
|
3.8%
1/26 • Number of events 2 • 1 year
|
|
Investigations
Cardiac troponin I increased
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Investigations
INR increased
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.6%
9/26 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
34.6%
9/26 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.2%
5/26 • Number of events 8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.4%
4/26 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
2/26 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
2/26 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
53.8%
14/26 • Number of events 21 • 1 year
|
|
Nervous system disorders
Dizziness
|
26.9%
7/26 • Number of events 9 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
15.4%
4/26 • Number of events 4 • 1 year
|
|
Nervous system disorders
Paresthesia
|
15.4%
4/26 • Number of events 5 • 1 year
|
|
Nervous system disorders
Amnesia
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Nervous system disorders
Tremor
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Nervous system disorders
Concentration impairment
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Facial muscle weakness
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Phantom pain
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Nervous system disorders
Vasovagal reaction
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
34.6%
9/26 • Number of events 10 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
23.1%
6/26 • Number of events 9 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.2%
5/26 • Number of events 7 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
26.9%
7/26 • Number of events 7 • 1 year
|
|
Infections and infestations
Skin infection
|
23.1%
6/26 • Number of events 6 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
19.2%
5/26 • Number of events 6 • 1 year
|
|
Infections and infestations
Lung infection
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
Infections and infestations
Conjunctivitis infective
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Papulopustular rash
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Thrush
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Tooth infection
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
42.3%
11/26 • Number of events 17 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
26.9%
7/26 • Number of events 8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.9%
7/26 • Number of events 9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
15.4%
4/26 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
26.9%
7/26 • Number of events 9 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
26.9%
7/26 • Number of events 8 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
2/26 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Insomnia
|
26.9%
7/26 • Number of events 7 • 1 year
|
|
Psychiatric disorders
Confusion
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Depression
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Hallucinations
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
19.2%
5/26 • Number of events 5 • 1 year
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Endocrine disorders
Adrenal insufficiency
|
3.8%
1/26 • Number of events 2 • 1 year
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Seroma
|
3.8%
1/26 • Number of events 2 • 1 year
|
|
General disorders
Fatigue
|
88.5%
23/26 • Number of events 37 • 1 year
|
|
General disorders
Pain
|
26.9%
7/26 • Number of events 9 • 1 year
|
|
General disorders
Edema limbs
|
15.4%
4/26 • Number of events 5 • 1 year
|
|
General disorders
Fever
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
General disorders
Flu like symptoms
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
General disorders
Localized edema
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
General disorders
Chills
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
7.7%
2/26 • Number of events 3 • 1 year
|
|
General disorders
Edema face
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
65.4%
17/26 • Number of events 30 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
38.5%
10/26 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Number of events 13 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
4/26 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
3/26 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Stomach pain
|
11.5%
3/26 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Belching
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Periodontal disease
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
88.5%
23/26 • Number of events 88 • 1 year
|
|
Vascular disorders
Hypotension
|
15.4%
4/26 • Number of events 7 • 1 year
|
|
Vascular disorders
Lymphedema
|
7.7%
2/26 • Number of events 2 • 1 year
|
|
Vascular disorders
Hematoma
|
3.8%
1/26 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.3%
11/26 • Number of events 27 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
38.5%
10/26 • Number of events 13 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
8/26 • Number of events 10 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.8%
8/26 • Number of events 14 • 1 year
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
26.9%
7/26 • Number of events 15 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.9%
7/26 • Number of events 21 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.4%
4/26 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place