Trial Outcomes & Findings for Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma (NCT NCT01142232)
NCT ID: NCT01142232
Last Updated: 2019-10-22
Results Overview
The number of patients who had a DLT during the dose finding portion (Phase I) of the trial for the safety of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
up to 1 month
Results posted on
2019-10-22
Participant Flow
This protocol was based on enrolling up to 16 patients phase I and up to 46 patients in phase II. The study enrolled 60 patients with 16 in phase I and 44 in phase II.
Participant milestones
| Measure |
Phase I, Dose Level 1
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
Phase II
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
6
|
44
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
5
|
34
|
Reasons for withdrawal
| Measure |
Phase I, Dose Level 1
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
Phase II
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
0
|
4
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease Progression
|
2
|
0
|
1
|
2
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
2
|
10
|
|
Overall Study
Alternative Therapy
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Off Trt for other complicating disease
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Noncompliance
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase I, Dose Level 1
n=3 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
n=4 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
n=3 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
n=6 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
Phase II
n=44 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
58.6 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
58.7 years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 1 monthPopulation: All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit (16 patients)
The number of patients who had a DLT during the dose finding portion (Phase I) of the trial for the safety of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=3 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
n=4 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
n=3 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
n=6 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|
|
Phase I: Number of Patients With Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: All Phase II patients who received at least one dose of study drug and had at least one evaluable post-baseline visit
Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better (CR+sCR+VGPR+PR). The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for Multiple Myeloma (CR= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow; sCR=CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunoflurorescence; VGPR=Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component\<100 mg per 24 h; PR=\>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200mg per 24 h).
Outcome measures
| Measure |
Phase I, Dose Level 1
n=40 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|
|
Phase II: Overall Response Rate
|
87.5 percentage of participants
Interval 73.2 to 95.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: All Phase II patients who received treatment.
Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.
Outcome measures
| Measure |
Phase I, Dose Level 1
n=44 Participants
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|
|
Phase II: Treatment-Related Adverse Events Grade 3 or Higher
|
18 Participants
|
—
|
—
|
—
|
Adverse Events
Phase I, Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I, Dose Level 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I, Dose Level 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I, Dose Level 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II
Serious events: 11 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I, Dose Level 1
n=3 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
n=4 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
n=3 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
n=6 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
Phase II
n=44 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Investigations
Investigations - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
66.7%
2/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
Other adverse events
| Measure |
Phase I, Dose Level 1
n=3 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
|
Phase I, Dose Level 2
n=4 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
|
Phase I, Dose Level 3
n=3 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
|
Phase I, Dose Level 4
n=6 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
Phase II
n=44 participants at risk
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
|
|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
100.0%
3/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
11.4%
5/44 • up to 5 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Vascular disorders
Vascular disorders - Other
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
27.3%
12/44 • up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
33.3%
1/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
27.3%
12/44 • up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
56.8%
25/44 • up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
100.0%
3/3 • up to 5 years
|
100.0%
6/6 • up to 5 years
|
88.6%
39/44 • up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
15.9%
7/44 • up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
66.7%
2/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
54.5%
24/44 • up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
100.0%
3/3 • up to 5 years
|
100.0%
6/6 • up to 5 years
|
88.6%
39/44 • up to 5 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
40.9%
18/44 • up to 5 years
|
|
General disorders
Chills
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
100.0%
3/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
31.8%
14/44 • up to 5 years
|
|
General disorders
Fatigue
|
100.0%
3/3 • up to 5 years
|
75.0%
3/4 • up to 5 years
|
100.0%
3/3 • up to 5 years
|
100.0%
6/6 • up to 5 years
|
72.7%
32/44 • up to 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
66.7%
2/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
50.0%
22/44 • up to 5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
General disorders
Localized edema
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
General disorders
Malaise
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
General disorders
Pain
|
0.00%
0/3 • up to 5 years
|
75.0%
3/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
45.5%
20/44 • up to 5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • up to 5 years
|
75.0%
3/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
18.2%
8/44 • up to 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
15.9%
7/44 • up to 5 years
|
|
Infections and infestations
Sinusitis
|
66.7%
2/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
13.6%
6/44 • up to 5 years
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
66.7%
2/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
34.1%
15/44 • up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
29.5%
13/44 • up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
13.6%
6/44 • up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
34.1%
15/44 • up to 5 years
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
66.7%
2/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
36.4%
16/44 • up to 5 years
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
18.2%
8/44 • up to 5 years
|
|
Investigations
INR increased
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • up to 5 years
|
75.0%
3/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
22.7%
10/44 • up to 5 years
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
15.9%
7/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
27.3%
12/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
3/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
13.6%
6/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
3/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
36.4%
16/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
13.6%
6/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
25.0%
11/44 • up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
18.2%
8/44 • up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
18.2%
8/44 • up to 5 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
2/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
66.7%
2/3 • up to 5 years
|
83.3%
5/6 • up to 5 years
|
36.4%
16/44 • up to 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
11.4%
5/44 • up to 5 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
22.7%
10/44 • up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • up to 5 years
|
75.0%
3/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
66.7%
4/6 • up to 5 years
|
29.5%
13/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
27.3%
12/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
6.8%
3/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • up to 5 years
|
50.0%
2/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
2.3%
1/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
33.3%
2/6 • up to 5 years
|
13.6%
6/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • up to 5 years
|
75.0%
3/4 • up to 5 years
|
33.3%
1/3 • up to 5 years
|
50.0%
3/6 • up to 5 years
|
31.8%
14/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
0.00%
0/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/3 • up to 5 years
|
25.0%
1/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
16.7%
1/6 • up to 5 years
|
11.4%
5/44 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
4.5%
2/44 • up to 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • up to 5 years
|
0.00%
0/4 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/6 • up to 5 years
|
9.1%
4/44 • up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place