Trial Outcomes & Findings for Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver (NCT NCT03472586)
NCT ID: NCT03472586
Last Updated: 2025-04-24
Results Overview
Defined as complete response + partial response + stable disease. Rated by Response Evaluation Criteria in Solid Tumors version 1.1. The estimate of the hepatic metastasis stabilization rate will be presented with corresponding 95% confidence intervals. The method of Atkinson and Brown will be used to adjust for the two-stage design.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Ipilimumab: Given IV
Nivolumab: Given IV
Embolization Therapy: Undergo immunoembolization
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Ipilimumab: Given IV
Nivolumab: Given IV
Embolization Therapy: Undergo immunoembolization
|
|---|---|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Death
|
6
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
Baseline characteristics by cohort
| Measure |
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
n=14 Participants
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Ipilimumab: Given IV
Nivolumab: Given IV
Embolization Therapy: Undergo immunoembolization
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.Defined as complete response + partial response + stable disease. Rated by Response Evaluation Criteria in Solid Tumors version 1.1. The estimate of the hepatic metastasis stabilization rate will be presented with corresponding 95% confidence intervals. The method of Atkinson and Brown will be used to adjust for the two-stage design.
Outcome measures
| Measure |
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
n=14 Participants
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Ipilimumab: Given IV
Nivolumab: Given IV
Embolization Therapy: Undergo immunoembolization
|
|---|---|
|
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Progressive disease
|
5 Participants
|
|
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Complete response
|
0 Participants
|
|
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Partial response
|
0 Participants
|
|
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Stable Disease
|
8 Participants
|
|
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Not Evaluated
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearGraded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity rates will be estimated with corresponding 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of the treatment to confirmation of progression of disease, assessed up to 1 yearWill be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of the treatment to confirmation of progression of disease, assessed up to 1 yearWill be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
n=14 participants at risk
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Ipilimumab: Given IV
Nivolumab: Given IV
Embolization Therapy: Undergo immunoembolization
|
|---|---|
|
Vascular disorders
grade 3 thromboembolic event that resulted in a hospitalization
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Hepatobiliary disorders
hepatic hemorrhage - grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 5
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Paresthesia - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Diarrhea - grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Colitis - grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
Other adverse events
| Measure |
Treatment (Ipilimumab, Nivolumab, Immunoembolization)
n=14 participants at risk
Patients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Ipilimumab: Given IV
Nivolumab: Given IV
Embolization Therapy: Undergo immunoembolization
|
|---|---|
|
General disorders
death - disease progression
|
42.9%
6/14 • Number of events 6 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Cardiac disorders
Tachycardia - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Ear and labyrinth disorders
Vertigo - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Chills - 0
|
71.4%
10/14 • Number of events 10 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Fatigue - Grade 0
|
50.0%
7/14 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Edema - extremities - grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Cardiac disorders
Pericardial Effusion - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Cardiac disorders
Tachycardia - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Ear and labyrinth disorders
Vertigo - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Endocrine disorders
Hyperthyroidism - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Endocrine disorders
Hypothyroidism - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Eye disorders
Blurred vision - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Eye disorders
Decreased vision - grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Chills - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Chills - Grade 2
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Fatigue - Grade 1
|
28.6%
4/14 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Fatigue - Grade 2
|
21.4%
3/14 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Edema - extremities - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Fever - Grade 0
|
50.0%
7/14 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Fever - Grade 1
|
35.7%
5/14 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Fever - Grade 2
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Flu-like symptoms - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Flu-like symptoms - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Edema - Localized - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Edema - Localized - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Non-cardiac chest pain - Grade 0
|
71.4%
10/14 • Number of events 10 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Non-cardiac chest pain - Grade 1
|
28.6%
4/14 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Pain - Grade 0
|
78.6%
11/14 • Number of events 11 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Pain - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Pain - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Pain - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Rigors - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
General disorders
Rigors - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Abdominal bloating - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Abdominal distension - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Abdominal pain - grade 0
|
21.4%
3/14 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Abdominal pain - Grade 1
|
64.3%
9/14 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Abdominal pain - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Abdominal pain - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Colitis - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Constipation - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Diarrhea - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Dry Mouth - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Dyspepsia - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Dysphagia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Flatulence - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Nausea - Grade 0
|
35.7%
5/14 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
42.9%
6/14 • Number of events 6 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
21.4%
3/14 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Vomiting - Grade 0
|
50.0%
7/14 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
35.7%
5/14 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Hepatobiliary disorders
Hepatic Pain - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Hepatobiliary disorders
Hepatic Pain - Grade 2
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
ALT increased - Grade 0
|
71.4%
10/14 • Number of events 10 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
ALT increased - Grade 3
|
21.4%
3/14 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
ALT increased - Grade 4
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
AST increased - Grade 0
|
71.4%
10/14 • Number of events 10 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
AST increased - Grade 3
|
21.4%
3/14 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
AST increased - Grade 4
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
Blood bilirubin increased - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
Blood bilirubin increased - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
Creatinine increased - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
Creatinine increased - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
Creatinine Kinase increased - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Investigations
Troponin Increased - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain - grade 0
|
64.3%
9/14 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 2
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Hand pain - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Hand pain - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Knee pain - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Hyponatremia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Weight loss - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Metabolism and nutrition disorders
Weight loss - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Dizziness - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Dysgeusia - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Dysgeusia - Grade 2
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Headache - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Larynsophageal Dysthesia - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Paresthesia - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Paresthesia - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Nervous system disorders
Peripheral Neuropathy - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Surgical and medical procedures
Postoperative hemorrhage - Grade 0
|
78.6%
11/14 • Number of events 11 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Surgical and medical procedures
Postoperative hemorrhage - Grade 1
|
14.3%
2/14 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Surgical and medical procedures
Postoperative hemorrhage - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Psychiatric disorders
Confusion - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Reproductive system and breast disorders
Scrotal edema - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Renal and urinary disorders
Urinary incontinence - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Erythematous Papule - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Pain at cath. site - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Pain at cath. site - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Pain at cath. site - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Rash - Maculopapular - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Rash - Pustular - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Skin and subcutaneous tissue disorders
Uticaria - Grade 0
|
100.0%
14/14 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Hematoma - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Hematoma - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Hypotension - Grade 0
|
85.7%
12/14 • Number of events 12 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Hypotension - Grade 1
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Hypotension - Grade 2
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Thromboembolic event - Grade 0
|
92.9%
13/14 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
|
Vascular disorders
Thromboembolic event - Grade 3
|
7.1%
1/14 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place