Trial Outcomes & Findings for Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma (NCT NCT03071406)
NCT ID: NCT03071406
Last Updated: 2025-12-22
Results Overview
Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2025-12-22
Participant Flow
Participant milestones
| Measure |
Arm A: Nivolumab + Ipilimumab
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Arm A: Nivolumab + Ipilimumab
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=18 Participants
|
4 Participants
n=102 Participants
|
10 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=18 Participants
|
21 Participants
n=102 Participants
|
40 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=18 Participants
|
6 Participants
n=102 Participants
|
11 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=18 Participants
|
19 Participants
n=102 Participants
|
39 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=18 Participants
|
25 Participants
n=102 Participants
|
50 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=18 Participants
|
25 Participants
n=102 Participants
|
50 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=18 Participants
|
25 participants
n=102 Participants
|
50 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Evaluable participants
Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR).
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
n=23 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
|---|---|---|
|
Best Overall Response
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 28 monthsMedian Progression Free Survival with 95% Confidence Interval. Progression is defined as progressive tumor lesions per immune-related Response Evaluation in Solid Tumors (irRECIST) definition, or appearance of one or more new Merkel cell carcinoma lesions, which can be local or distant in location from the irradiated lesions.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
27.7 months
Interval 9.2 to
Not reached: the upper limit of the 95% confidence interval could not be calculated due to an insufficient number of participants with events
|
7.6 months
Interval 2.8 to
Not reached: the upper limit of the 95% confidence interval could not be calculated due to an insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 30 monthsMedian Overall Survival with 95% Confidence Interval. The length of time from the start of treatment until death from any cause.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
n=25 Participants
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
|---|---|---|
|
Overall Survival (OS)
|
29.9 months
Interval 27.7 to
Not reached: the upper limit of the 95% confidence interval could not be calculated due to an insufficient number of participants with events
|
16 months
Interval 11.3 to
Not reached: the upper limit of the 95% confidence interval could not be calculated due to an insufficient number of participants with events
|
Adverse Events
Arm A: Nivolumab + Ipilimumab
Serious events: 13 serious events
Other events: 25 other events
Deaths: 11 deaths
Arm B: Nivolumab + Ipilimumab + SBRT
Serious events: 13 serious events
Other events: 25 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Arm A: Nivolumab + Ipilimumab
n=25 participants at risk
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
n=25 participants at risk
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Myocarditis-autoimmune
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Enterocolitis infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Atrial fibrilation
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Gastric ulcer
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Hepatobiliary disorders
Biliary obstruction
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Lipase increased
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Gallbladder obstruction
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal fold paralysis
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
MRSA
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Wound infection
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Death NOS
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Infections and infestations - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Generalized weakness
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
Other adverse events
| Measure |
Arm A: Nivolumab + Ipilimumab
n=25 participants at risk
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
|
Arm B: Nivolumab + Ipilimumab + SBRT
n=25 participants at risk
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
Nivolumab: Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Ipilimumab: Ipilimumab 1 mg/kg/dose IV q6 weeks.
Stereotactic Body Radiation Therapy (SBRT): Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
|
|---|---|---|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Localized edema
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Death NOS
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Edema face
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Gait disturbance
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Irritability
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Malaise
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
10/25 • Number of events 21 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
52.0%
13/25 • Number of events 28 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
44.0%
11/25 • Number of events 17 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
40.0%
10/25 • Number of events 12 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
32.0%
8/25 • Number of events 15 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
20.0%
5/25 • Number of events 7 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.0%
4/25 • Number of events 7 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
32.0%
8/25 • Number of events 12 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
28.0%
7/25 • Number of events 9 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
32.0%
8/25 • Number of events 12 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Stomach pain
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Gastric ulcer
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratoses
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Itching rash
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Minor rash
|
32.0%
8/25 • Number of events 10 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Macular rash
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissues disorders - Other
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.0%
11/25 • Number of events 18 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
40.0%
10/25 • Number of events 15 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.0%
3/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
24.0%
6/25 • Number of events 14 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Weight loss
|
32.0%
8/25 • Number of events 12 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
24.0%
6/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Lipase increased
|
28.0%
7/25 • Number of events 15 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 14 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Serum amylase increased
|
28.0%
7/25 • Number of events 19 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
28.0%
7/25 • Number of events 21 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Alanine aminotransferase increased
|
24.0%
6/25 • Number of events 35 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Platelet count decreased
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Creatinine increased
|
4.0%
1/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Weight gain
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
White blood cell decreased
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
CPK increased
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Investigations
Urine output decreased
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.0%
8/25 • Number of events 13 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
44.0%
11/25 • Number of events 14 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
5/25 • Number of events 7 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
32.0%
8/25 • Number of events 11 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
20.0%
5/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.0%
2/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
5/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
48.0%
12/25 • Number of events 14 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.0%
7/25 • Number of events 12 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
20.0%
5/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
5/25 • Number of events 9 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
24.0%
6/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.0%
6/25 • Number of events 14 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
1/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.0%
7/25 • Number of events 14 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
28.0%
7/25 • Number of events 16 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
5/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.0%
2/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Headache
|
24.0%
6/25 • Number of events 12 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
28.0%
7/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
24.0%
6/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Nervous system disorders - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Memory impairment
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Parasthesia
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Syncope
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Concentration impairment
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Presyncope
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Tremor
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Nervous system disorders
Vasovagal reaction
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
32.0%
8/25 • Number of events 11 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
28.0%
7/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
5/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Endocrine disorders
Adrenal insufficiency
|
20.0%
5/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Endocrine disorders
Hyperthyroidism
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Endocrine disorders
Endocrine disorders -Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Kidney infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Wound infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Rash pustular
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Infections and infestations
Vaginal infection
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
24.0%
6/25 • Number of events 11 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
28.0%
7/25 • Number of events 13 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Psychiatric disorders
Depression
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Psychiatric disorders
Confusion
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
16.0%
4/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Vascular disorders
Lymphedema
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Vascular disorders
Hematoma
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Blurred vision
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
12.0%
3/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Dry eye
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Blepharitis
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Stye
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Eye disorders - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Conjunctivitis
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Watering eyes
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Eye disorders
Photophobia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Hematuria
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Renal calculi
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Renal colic
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Renal and urinary disorders
Urine discoloration
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Heart murmur
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Tachycardia
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Cardiac disorders - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
12.0%
3/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Myocarditis
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Palpitations
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Sinus brachycardia
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
12.0%
3/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.0%
4/25 • Number of events 5 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.0%
2/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders -Other
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Ear and labyrinth disorders
Ear pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Ear and labyrinth disorders
External ear inflammation
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Hepatobiliary disorders
Biliary obstruction
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Immune system disorders
Autoimmune disorder
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Immune system disorders
Systemic inflammation syndrome
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
Reproductive system and breast disorders
Testicular pain
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
0.00%
0/25 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Fatigue
|
76.0%
19/25 • Number of events 37 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
60.0%
15/25 • Number of events 23 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Edema limbs
|
28.0%
7/25 • Number of events 9 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
36.0%
9/25 • Number of events 11 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Pain
|
24.0%
6/25 • Number of events 6 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
20.0%
5/25 • Number of events 8 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
General disorders and administration site conditions - Other
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Fever
|
16.0%
4/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 2 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Flu like symptoms
|
12.0%
3/25 • Number of events 4 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
|
General disorders
Infusion related reaction
|
8.0%
2/25 • Number of events 3 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
4.0%
1/25 • Number of events 1 • Adverse events collected from on study date to 100 days after end of treatment (an average of 10.5 months). Survival will be assessed up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place