Trial Outcomes & Findings for Neoadjuvant and Adjuvant Checkpoint Blockade (NCT NCT02519322)
NCT ID: NCT02519322
Last Updated: 2024-04-05
Results Overview
Number of participants with the Pathologic response rate will be assessed by percent viable tumor cells, percent tumor necrosis, presence of fibrosis and melanoma proliferation as assessed by phosphohistone H3 from baseline, to on-treatment and surgical specimens.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
up to 2 years
Results posted on
2024-04-05
Participant Flow
Randomized non-comparative sugy of neoadjuvant nivolumab monothereapy or nivolumab combined with ipilimumab followed by adjuvant nivolumab or nivolumabe combined with relatlimab in adult (\> 18 years) subjects with resectable, high-risk melanoma.
The number of participants enrolled were 53. However, data was not captured for 19 participants in Arms A \& B. 34 participants in Arm C were treated.
Participant milestones
| Measure |
Arm A (Nivolumab, Surgery)
Participants receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Participants then undergo surgery on day 57. After surgery, patients receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Participants receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Patients then undergo surgery on day 57. After surgery, Participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Participants then undergo surgery on day 57. After surgery, Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
34
|
|
Overall Study
COMPLETED
|
0
|
0
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant and Adjuvant Checkpoint Blockade
Baseline characteristics by cohort
| Measure |
Arm A (Nivolumab, Surgery)
Nivolumab IV over 30 minutes D1, 15, 29, \& 43; Surgery D57; Post-surgery Nivolumab IV over 30 minutes Q2wks for 13 doses
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Nivolumab IV ocer 1 hr and ipilimumab IV over 90 minutes D1, 22, \& 43; Surgery D57; Nivolumab IV over 30 minutes Q2wks for 13 doses
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 Participants
Nivolumab IV and relatilmab IV over 1 hr D1 and D29; Surgery D57; Post-surgery Nivolumab IV and relatimab IV over 1 hr Q4wks for 10 doses
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: No data to report due to study Closed to entry as of 07/2017 regarding Arm A and Arm B.
Number of participants with the Pathologic response rate will be assessed by percent viable tumor cells, percent tumor necrosis, presence of fibrosis and melanoma proliferation as assessed by phosphohistone H3 from baseline, to on-treatment and surgical specimens.
Outcome measures
| Measure |
Arm A (Nivolumab, Surgery)
Participants receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Participants receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 Participants
Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Arm C: Number of Participants With the Pathologic Response Rate
|
0 Participants
|
0 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: No data to report due to study Closed to entry as of 07/2017 regarding Arm A and Arm B.
Number of Participants assessed by the safety and feasibility of relatlimab with nivolumab Delivered in the Neoadjuvant Setting
Outcome measures
| Measure |
Arm A (Nivolumab, Surgery)
Participants receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Participants receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 Participants
Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Arm C: Number of Participants Assessed by Safety and Feasibility of Relatlimab With Nivolumab Delivered in the Neoadjuvant Setting
|
0 Participants
|
0 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No data to report due to study Closed to entry as of 07/2017 regarding Arm A and Arm B.
To assess the objective response rate (ORR) of relatlimab with nivolumab administered in the neoadjuvant setting as assessed by imaging (RECIST 1.1 criteria) in participants with high-risk resectable melanoma
Outcome measures
| Measure |
Arm A (Nivolumab, Surgery)
Participants receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Participants receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 Participants
Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Arm C: Number of Participants With Objective Response Rate (ORR) of Relatlimab With Nivolumab Administered in the Neoadjuvant Setting.
|
0 Participants
|
0 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: No data to report due to study Closed to entry as of 07/2017 regarding Arm A and Arm B.
To assess the 12-month recurrence and overall survival (OS) of participants with high-risk resectable melanoma treated with neoadjuvant and adjuvant relatlimab with nivolumab
Outcome measures
| Measure |
Arm A (Nivolumab, Surgery)
Participants receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Participants receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 Participants
Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Arm C: Number of Participants With Recurrence-Free Survival (RFS) and Overall Survival (OS)
|
0 Participants
|
0 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: No data to report due to study Closed to entry as of 07/2017 regarding Arm A and Arm B.
To assess by immunologic and molecular mechanisms of response and resistance to relatlimab with nivolumab.
Outcome measures
| Measure |
Arm A (Nivolumab, Surgery)
Participants receive nivolumab IV over 30 minutes on days 1, 15, 29, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Participants receive nivolumab IV over 1 hour and ipilimumab IV over 90 minutes on days 1, 22, and 43. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 30 minutes every 2 weeks for 13 doses in the absence of disease progression or unacceptable toxicity.
Ipilimumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 Participants
Participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour on days 1 and 29. Participants then undergo surgery on day 57. After surgery, participants receive nivolumab IV over 1 hour and relatlimab IV over 1 hour every 4 weeks for 10 doses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Arm C: Number of Participants With Immunologic and Molecular Mechanisms of Response and Resistance.
|
0 Participants
|
0 Participants
|
34 Participants
|
Adverse Events
Arm A (Nivolumab, Surgery)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B (Nivolumab, Ipilimumab, Surgery)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm C (Nivolumab, Relatlimab, Surgery)
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Nivolumab, Surgery)
Nivolumab IV over 30 minutes D1, 15, 29 \& 43; surgery D57; post-surgery nivolumab IV over 30 minutes for Q2wks for 13 doses
|
Arm B (Nivolumab, Ipilimumab, Surgery)
Nivolumab IV ocer 1 hr and ipilimumab IV over 90 minutes D1, 22, \& 43; Surgery D57; Nivolumab IV over 30 minutes Q2wks for 13 doses
Nivolumab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
Arm C (Nivolumab, Relatlimab, Surgery)
n=34 participants at risk
Nivolumab IV ocer 1 hr and ipilimumab IV over 90 minutes D1, 22, \& 43; Surgery D57; Nivolumab IV over 30 minutes Q2wks for 13 doses
Relatlimab: Given IV
Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
52.9%
18/34 • Number of events 25 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Abdominal Pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
6.1%
2/33 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
Adrenal insufficiency
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
23.5%
8/34 • Number of events 11 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Psychiatric disorders
Agitation
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
41.2%
14/34 • Number of events 23 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 14 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
58.8%
20/34 • Number of events 37 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
26.5%
9/34 • Number of events 11 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Anxiety
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 7 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 16 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 14 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 7 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Bloating
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Blood and lymphatic system disorders
Ischemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Blood bilirubin increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Eye disorders
Blurred Vision
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 8 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Injury, poisoning and procedural complications
Bruising
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Mitral Valve Prolapse
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Tropinin T Increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 18 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Hemoptsis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Tropinin I increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Chills
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
17.6%
6/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Colitis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Concentration impairment
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Confusion
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
38.2%
13/34 • Number of events 17 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
52.9%
18/34 • Number of events 23 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
CPK increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Creatinine increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
41.2%
14/34 • Number of events 29 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Immune system disorders
Cytokine release syndrome
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Psychiatric disorders
Depression
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
44.1%
15/34 • Number of events 27 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
23.5%
8/34 • Number of events 11 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Eye disorders
Dry Eye
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Dry Mouth
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 10 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Dysgeusia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
17.6%
6/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Ear and labyrinth disorders
Fullmess of ears
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Ear and labyrinth disorders
Ear pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Edema limbs
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
TSH increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
17.6%
6/34 • Number of events 8 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
Elevated Free T4
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
Decreased TSH
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
Low T4
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Facial muscle weakness
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Fatigue
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
73.5%
25/34 • Number of events 43 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Fever
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 18 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Flu like symptoms
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 7 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Gait disturbance
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Gastritis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Loose stools
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Hemoptysis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Vascular disorders
Hematoma
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Genrealized muscle weakmess
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 8 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
73.5%
25/34 • Number of events 67 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Vascular disorders
Hypertension
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 20 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
Hyperthyrodism
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
17.6%
6/34 • Number of events 10 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 8 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
52.9%
18/34 • Number of events 28 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Vascular disorders
Hypotension
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Endocrine disorders
Hypothyrodism
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
35.3%
12/34 • Number of events 13 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 7 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
INR Increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Localized Edema
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Vascular disorders
Lymphedema
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 12 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Malaise
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Mucositis (Oral)
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
23.5%
8/34 • Number of events 12 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
35.3%
12/34 • Number of events 13 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
50.0%
17/34 • Number of events 27 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Neck edema
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Neck pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Neutorphil count decreased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Non-cardiac chest pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
47.1%
16/34 • Number of events 23 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
23.5%
8/34 • Number of events 9 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Papulopustular rash
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 8 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 7 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Platelet count decreased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
61.8%
21/34 • Number of events 29 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
General disorders
Rash maculo-papular
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
55.9%
19/34 • Number of events 32 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Sinusitis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 5 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Sking Hypopigmentation
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
14.7%
5/34 • Number of events 7 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Skin Infection
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
23.5%
8/34 • Number of events 17 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
17.6%
6/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Syncope
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Ear and labyrinth disorders
Tinnitus
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Toothache
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Renal and urinary disorders
Urinary Tract infection
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Ear and labyrinth disorders
Vertigo
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
29.4%
10/34 • Number of events 14 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Weight Loss
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
20.6%
7/34 • Number of events 18 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Injury, poisoning and procedural complications
Wound complication
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Troponin I increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Congenital, familial and genetic disorders
Sinus congestion
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
11.8%
4/34 • Number of events 6 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Eye disorders
Weakness to left eyelid
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Eye disorders
Pain (bil eye lieds)
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Eye disorders
Lower lid redness
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Eye disorders
Photosensitivity
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Fecal incontinence
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Injury, poisoning and procedural complications
Fracture
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Gum infection
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Ear and labyrinth disorders
Hearing impaired
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Hemorrhoids
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Ear infection
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
COVID-19
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Joint rang of motion decreased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Lipase increased
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Lung Infections
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Memory impairment
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (left-sided)
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (lower limb)
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness-trunk
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis (left foot)
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Myocarditis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Neurlgia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Oral pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Palpations
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 4 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Renal and urinary disorders
Rectal hemorrhage
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Renal and urinary disorders
Renal hemorrhage
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Sinus Bradycardia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Cardiac disorders
Sinus Tachycardia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Soft tissue infection
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Gastrointestinal disorders
Stomach pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Nervous system disorders
Tremor
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Renal and urinary disorders
Uringary tract pain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Investigations
Weight gain
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Psychiatric disorders
Amnesia
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Mood swings
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
8.8%
3/34 • Number of events 3 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
—
0/0 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
5.9%
2/34 • Number of events 2 • Baseline to 2 years post treatment
No participants were analyzed in Arm A and Arm B, only in Arm C.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place