Trial Outcomes & Findings for Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma (NCT NCT03000179)
NCT ID: NCT03000179
Last Updated: 2022-04-14
Results Overview
Response rate is the proportion of patients with overall complete (CR) or partial response(PR) among patients with valuable response outcome. Overall response will consider both target and non-target lesions, as well as new lesions. Target lesions by CT/MRI: CR: Disappearance of all target lesions. PR: \>= 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions, In addition, the sum must also demonstrate an absolute increase of at least 5 mm or appearance of new lesions. Non-target lesions: CR: Disappearance of all target lesions. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of applicable tumor marker level above the normal limits. PD: progression of existing non-target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Measured every 8 weeks through study completion, an average of 1 year
Results posted on
2022-04-14
Participant Flow
Participants were enrolled onto this study at Vanderbilt University Medical Center in Nashville, TN from March 2017 to August 2019. The study closed early due to low accrual.
Participant milestones
| Measure |
Avelumab Monotherapy
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Avelumab Monotherapy
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Avelumab Monotherapy
n=8 Participants
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Measured every 8 weeks through study completion, an average of 1 yearPopulation: Patients with advanced small intestinal adenocarcinoma or ampullary tumors, efficacy-evaluable.
Response rate is the proportion of patients with overall complete (CR) or partial response(PR) among patients with valuable response outcome. Overall response will consider both target and non-target lesions, as well as new lesions. Target lesions by CT/MRI: CR: Disappearance of all target lesions. PR: \>= 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): \>= 20% increase in the sum of diameters of target lesions, In addition, the sum must also demonstrate an absolute increase of at least 5 mm or appearance of new lesions. Non-target lesions: CR: Disappearance of all target lesions. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of applicable tumor marker level above the normal limits. PD: progression of existing non-target lesions.
Outcome measures
| Measure |
Avelumab Monotherapy
n=7 Participants
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Overall Response Rate as Measured Using RECIST 1.1
|
0.29 proportion of participants
Interval 0.08 to 0.64
|
PRIMARY outcome
Timeframe: On-study date to 30 days following final dose of study drug, or until the event is resolved, stabilized, or determined to be irreversible by the participating investigator if beyond 30 days.Population: all participants
To describe the safety profile of avelumab monotherapy in patients with advanced or metastatic small intestinal adenocarcinoma
Outcome measures
| Measure |
Avelumab Monotherapy
n=8 Participants
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Number of Patients With Each Worst-Grade Toxicity
Anemia, Grade 1
|
2 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Fatigue, Grade2
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Infusion related reaction. Grade2
|
2 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Alanine aminotransferase increased, Grade 1
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Alkaline phosphatase increased, Grade 1
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Anorexia, Grade 2
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Blood bilirubin increased, Grade1
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Diarrhea, Grade 1
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Diabetic ketoacidosis, Grade 4
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Back pain, Grade 1
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Diverticulitis per upper GI series, Grade 2
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Hypokalemia, Grade 3
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Hyponatremia, Grade 3
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Nausea, Grade 2
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Rash maculo-papular, Grade 1
|
1 Participants
|
|
Number of Patients With Each Worst-Grade Toxicity
Urticaria, Grade 1
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 3 months after completing treatment up to 5 yearsPopulation: all participants
On study date until death from any cause
Outcome measures
| Measure |
Avelumab Monotherapy
n=8 Participants
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Overall Survival
|
6.4 months
Interval 3.8 to
Insufficient number of patients with the death event
|
SECONDARY outcome
Timeframe: On-study date to lesser of date of progression or date of death from any cause measured up to 3 years after treatmentPopulation: all participants
On-study date until disease progression or death. Progression is \>= 20% increase in the sum of diameters of target lesions or non-target lesions, or appearance of new lesions.
Outcome measures
| Measure |
Avelumab Monotherapy
n=8 Participants
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Progression Free Survival
|
3.4 months
Interval 3.0 to
Insufficient number of patients with progression.
|
SECONDARY outcome
Timeframe: Date of first partial or complete response as defined by RECIST 1.1 criteria to date of recurrence or disease progression up to 3 yearsPopulation: Patients who had partial response.
Time from tumor response date to disease progression or death for any reason.
Outcome measures
| Measure |
Avelumab Monotherapy
n=2 Participants
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Duration of Response
|
10.9 months
Interval 3.0 to 18.8
|
Adverse Events
Avelumab Monotherapy
Serious events: 7 serious events
Other events: 8 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Avelumab Monotherapy
n=8 participants at risk
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Endocrine disorders
Diabetic Ketoacidos
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Gastroenteritis
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
Ataxia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Infections and infestations
Bacteremia bloodstream infection
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Colonic obstruction
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Sepsis
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
Other adverse events
| Measure |
Avelumab Monotherapy
n=8 participants at risk
Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks.
Avelumab: Avelumab through a vein once every 2 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
62.5%
5/8 • Number of events 7 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 7 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 6 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 3 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
7/8 • Number of events 20 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
4/8 • Number of events 8 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Alkaline phosphatase increased
|
37.5%
3/8 • Number of events 8 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Weight loss
|
37.5%
3/8 • Number of events 5 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
2/8 • Number of events 3 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Blood bilirubin increased
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
INR increased
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 5 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Fever
|
25.0%
2/8 • Number of events 4 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Limb edema
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Facial pain
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Gait disturbance
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
General disorders
Infusion related reaction
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
3/8 • Number of events 8 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • Number of events 5 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Investigations
Hypocalcemia
|
25.0%
2/8 • Number of events 7 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Infections and infestations
Mucosal infection
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Infections and infestations
Small intestine infection
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 3 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
Syncope
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
memory impairement
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Number of events 3 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Couph
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 3 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Nervous system disorders
Thromboembolic event
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Vascular disorders
Phlebitis
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
2/8 • Number of events 4 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weaknes
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Psychiatric disorders
Confusion
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Psychiatric disorders
Psychosis
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Psychiatric disorders
Restlessness
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Renal and urinary disorders
Proteinuria
|
37.5%
3/8 • Number of events 3 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Cardiac disorders
Chest pain
|
12.5%
1/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
2/8 • Number of events 2 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Endocrine disorders
Adrenal insufficiency
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
|
Eye disorders
Blurred vision
|
12.5%
1/8 • Number of events 1 • From study entry to up to 28 days from the last dose of avelumab up to approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place