Trial Outcomes & Findings for Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia (NCT NCT01420926)
NCT ID: NCT01420926
Last Updated: 2023-02-28
Results Overview
Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
48 months
Results posted on
2023-02-28
Participant Flow
165 participants were enrolled from 24 sites from November 2011 to March 2013
Two (2) participants never received any protocol treatment; per study design these patients were excluded from all analyses.
Participant milestones
| Measure |
Arm I (Decitabine)
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
60
|
63
|
Reasons for withdrawal
| Measure |
Arm I (Decitabine)
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Death
|
18
|
17
|
|
Overall Study
Withdrawal by Subject
|
11
|
17
|
|
Overall Study
Non-protocol treatment
|
17
|
20
|
|
Overall Study
Physician Decision
|
8
|
5
|
Baseline Characteristics
Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (Decitabine)
n=82 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=81 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.4 years
n=5 Participants
|
72.9 years
n=7 Participants
|
72.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
81 participants
n=7 Participants
|
163 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 monthsOverall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm I (Decitabine)
n=82 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=81 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) Time
|
9.3 months
Interval 5.8 to 12.2
|
8.8 months
Interval 3.8 to 14.3
|
SECONDARY outcome
Timeframe: 48 monthsDefined as the number of patients who achieve a CR or CRi divided by the total number of evaluable patients. A Complete remission (CR) requires: \<5% marrow blast, \> 200 nucleated cells, no blasts with auer rods, no extramedullary disease, ANC \>1,000/mm\^3 and platelets \> 100,000/mm\^3. A CR with incomplete blood count recovery (CRi) is defined as CR with exception of ANC \< 1,000/mm\^3 or platelets \< 100,000/mm\^3.
Outcome measures
| Measure |
Arm I (Decitabine)
n=82 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=81 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Complete Remission Rate (CR and CRi)
|
40 percentage of participants
Interval 30.0 to 52.0
|
38 percentage of participants
Interval 28.0 to 50.0
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Only participants who achieved a CR are included in this analysis.
Disease free survival (DFS) was defined as the time from CR to relapse or death. Relapse free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method. Relapse is defined as the reappearance of blood blasts or \>= 5% marrow blasts after achieving a CR or CRi.
Outcome measures
| Measure |
Arm I (Decitabine)
n=15 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=17 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease-free Survival (DFS)
|
8.5 months
Interval 3.9 to 21.3
|
15.3 months
Interval 7.9 to 25.5
|
SECONDARY outcome
Timeframe: 48 monthsProgression free survival (PFS) was defined as the time from study entry to progression or death. Progression free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm I (Decitabine)
n=82 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=81 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
7.3 months
Interval 5.3 to 8.9
|
8.0 months
Interval 3.8 to 12.2
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: The 4 participants were not evaluated for adverse events were excluded from this analysis.
Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
Outcome measures
| Measure |
Arm I (Decitabine)
n=80 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=79 Participants
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Adverse Events
|
51 participants
|
45 participants
|
Adverse Events
Arm I (Decitabine)
Serious events: 43 serious events
Other events: 66 other events
Deaths: 70 deaths
Arm II (Decitabine and Bortezomib)
Serious events: 45 serious events
Other events: 61 other events
Deaths: 75 deaths
Serious adverse events
| Measure |
Arm I (Decitabine)
n=80 participants at risk
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=79 participants at risk
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
40/80 • Number of events 51 • 48 months
159 participants were evaluable for adverse events.
|
49.4%
39/79 • Number of events 52 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.5%
2/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
20/80 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
29.1%
23/79 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
8/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Cardiac disorders - Other
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Heart failure
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Palpitations
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Pericardial tamponade
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
11.2%
9/80 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.8%
3/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Blurred vision
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Eye disorders - Other
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Eye pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Floaters
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Watering eyes
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
10/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Anal pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Bloating
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colonic fistula
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
21.2%
17/80 • Number of events 20 • 48 months
159 participants were evaluable for adverse events.
|
20.3%
16/79 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
17.5%
14/80 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
27.8%
22/79 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.8%
7/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
26.2%
21/80 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
26.6%
21/79 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Typhlitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
16/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
17.7%
14/79 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Chills
|
11.2%
9/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Death NOS
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Edema face
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Edema limbs
|
21.2%
17/80 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
29.1%
23/79 • Number of events 28 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Edema trunk
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Fatigue
|
36.2%
29/80 • Number of events 38 • 48 months
159 participants were evaluable for adverse events.
|
34.2%
27/79 • Number of events 35 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Fever
|
8.8%
7/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Flu like symptoms
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
General disorders and administration site conditions - Other
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Hypothermia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Infusion related reaction
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Injection site reaction
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Localized edema
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Malaise
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Multi-organ failure
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Pain
|
10.0%
8/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Immune system disorders
Allergic reaction
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Catheter related infection
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Cecal infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Esophageal infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Eye infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Gum infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other
|
10.0%
8/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
13.9%
11/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Joint infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Lip infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Lung infection
|
17.5%
14/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
16.5%
13/79 • Number of events 16 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Mucosal infection
|
3.8%
3/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Penile infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Pleural infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Sepsis
|
15.0%
12/80 • Number of events 13 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Sinusitis
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Skin infection
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Wound infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
8/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
16.2%
13/80 • Number of events 15 • 48 months
159 participants were evaluable for adverse events.
|
19.0%
15/79 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
8/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
15/80 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
25.3%
20/79 • Number of events 22 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Blood bilirubin increased
|
26.2%
21/80 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Cardiac troponin I increased
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Cholesterol high
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Creatinine increased
|
21.2%
17/80 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
24.1%
19/79 • Number of events 26 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Ejection fraction decreased
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
GGT increased
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
INR increased
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Investigations - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Lipase increased
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
17.5%
14/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
21.5%
17/79 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Neutrophil count decreased
|
46.2%
37/80 • Number of events 47 • 48 months
159 participants were evaluable for adverse events.
|
48.1%
38/79 • Number of events 51 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Platelet count decreased
|
48.8%
39/80 • Number of events 47 • 48 months
159 participants were evaluable for adverse events.
|
46.8%
37/79 • Number of events 48 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Urine output decreased
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Weight gain
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Weight loss
|
8.8%
7/80 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
White blood cell decreased
|
25.0%
20/80 • Number of events 27 • 48 months
159 participants were evaluable for adverse events.
|
22.8%
18/79 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
16/80 • Number of events 21 • 48 months
159 participants were evaluable for adverse events.
|
22.8%
18/79 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
24/80 • Number of events 33 • 48 months
159 participants were evaluable for adverse events.
|
31.6%
25/79 • Number of events 33 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
4/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
5/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.2%
21/80 • Number of events 28 • 48 months
159 participants were evaluable for adverse events.
|
32.9%
26/79 • Number of events 32 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.8%
19/80 • Number of events 21 • 48 months
159 participants were evaluable for adverse events.
|
24.1%
19/79 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.2%
17/80 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
26.6%
21/79 • Number of events 29 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
16/80 • Number of events 21 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
20/80 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
24.1%
19/79 • Number of events 22 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
8/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Iron overload
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
7/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.8%
11/80 • Number of events 16 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Cognitive disturbance
|
1.2%
1/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Dizziness
|
11.2%
9/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Dysarthria
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Headache
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
13.9%
11/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Lethargy
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Nervous system disorders - Other
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Presyncope
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Seizure
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Sinus pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Somnolence
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Stroke
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Syncope
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Agitation
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Anxiety
|
8.8%
7/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Confusion
|
8.8%
7/80 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Delirium
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Delusions
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Depression
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Hallucinations
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Insomnia
|
12.5%
10/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.8%
7/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Hematuria
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
5/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal calculi
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Penile pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.8%
7/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
20/80 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
16.5%
13/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.5%
18/80 • Number of events 20 • 48 months
159 participants were evaluable for adverse events.
|
29.1%
23/79 • Number of events 29 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
8/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
8/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
3/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
10/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
7.5%
6/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
13.9%
11/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hematoma
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hot flashes
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypertension
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
13.9%
11/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypotension
|
20.0%
16/80 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
21.5%
17/79 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Vascular disorders - Other
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
Other adverse events
| Measure |
Arm I (Decitabine)
n=80 participants at risk
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Decitabine and Bortezomib)
n=79 participants at risk
REMISSION INDUCTION THERAPY: Patients receive 20 mg/m\^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m\^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.
CONTINUATION THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive 1.3 mg/m\^2 bortezomib SC on day 1 and 20 mg/m\^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
78.8%
63/80 • Number of events 253 • 48 months
159 participants were evaluable for adverse events.
|
74.7%
59/79 • Number of events 239 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.8%
3/80 • Number of events 13 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
42.5%
34/80 • Number of events 53 • 48 months
159 participants were evaluable for adverse events.
|
41.8%
33/79 • Number of events 45 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
4/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Cardiac disorders - Other
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Heart failure
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Palpitations
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
11.2%
9/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Blurred vision
|
5.0%
4/80 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Conjunctivitis
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Dry eye
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Eye disorders - Other
|
2.5%
2/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Eye pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Vitreous hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Eye disorders
Watering eyes
|
1.2%
1/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
8/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
19.0%
15/79 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Anal pain
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Bloating
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
47.5%
38/80 • Number of events 78 • 48 months
159 participants were evaluable for adverse events.
|
43.0%
34/79 • Number of events 65 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dental caries
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
42.5%
34/80 • Number of events 60 • 48 months
159 participants were evaluable for adverse events.
|
41.8%
33/79 • Number of events 48 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
7/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
7/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Esophagitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.8%
7/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
17.5%
14/80 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
16.5%
13/79 • Number of events 16 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
42.5%
34/80 • Number of events 67 • 48 months
159 participants were evaluable for adverse events.
|
43.0%
34/79 • Number of events 95 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
8/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Peritoneal necrosis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Stomach pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Typhlitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
16.2%
13/80 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
25.3%
20/79 • Number of events 36 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Chills
|
11.2%
9/80 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
20.3%
16/79 • Number of events 21 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Edema face
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Edema limbs
|
40.0%
32/80 • Number of events 58 • 48 months
159 participants were evaluable for adverse events.
|
31.6%
25/79 • Number of events 51 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Edema trunk
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Facial pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Fatigue
|
66.2%
53/80 • Number of events 173 • 48 months
159 participants were evaluable for adverse events.
|
64.6%
51/79 • Number of events 170 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Fever
|
18.8%
15/80 • Number of events 16 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Flu like symptoms
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Gait disturbance
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
General disorders and administration site conditions - Other
|
10.0%
8/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Infusion related reaction
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Injection site reaction
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Localized edema
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Malaise
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
General disorders
Pain
|
12.5%
10/80 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Immune system disorders
Allergic reaction
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Bronchial infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Catheter related infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Conjunctivitis infective
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Gallbladder infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Gum infection
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Hepatitis viral
|
1.2%
1/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other
|
8.8%
7/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
13.9%
11/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Joint infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Lip infection
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Lung infection
|
17.5%
14/80 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Mucosal infection
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Nail infection
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Paronychia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Pharyngitis
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Salivary gland infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Sepsis
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Sinusitis
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Skin infection
|
11.2%
9/80 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Small intestine infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Tooth infection
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
8.8%
7/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Infections and infestations
Wound infection
|
3.8%
3/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
15.0%
12/80 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
3/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
12.7%
10/79 • Number of events 12 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.2%
5/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
27.5%
22/80 • Number of events 38 • 48 months
159 participants were evaluable for adverse events.
|
24.1%
19/79 • Number of events 44 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
21.2%
17/80 • Number of events 34 • 48 months
159 participants were evaluable for adverse events.
|
19.0%
15/79 • Number of events 29 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
35.0%
28/80 • Number of events 40 • 48 months
159 participants were evaluable for adverse events.
|
34.2%
27/79 • Number of events 54 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Blood bilirubin increased
|
25.0%
20/80 • Number of events 44 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 16 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Blood prolactin abnormal
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Cardiac troponin I increased
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Cholesterol high
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Creatinine increased
|
18.8%
15/80 • Number of events 26 • 48 months
159 participants were evaluable for adverse events.
|
25.3%
20/79 • Number of events 62 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
GGT increased
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Hemoglobin increased
|
2.5%
2/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
INR increased
|
12.5%
10/80 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
16.5%
13/79 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Investigations - Other
|
6.2%
5/80 • Number of events 20 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 26 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
23.8%
19/80 • Number of events 45 • 48 months
159 participants were evaluable for adverse events.
|
22.8%
18/79 • Number of events 54 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Lymphocyte count increased
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Neutrophil count decreased
|
77.5%
62/80 • Number of events 266 • 48 months
159 participants were evaluable for adverse events.
|
70.9%
56/79 • Number of events 224 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Platelet count decreased
|
77.5%
62/80 • Number of events 233 • 48 months
159 participants were evaluable for adverse events.
|
74.7%
59/79 • Number of events 236 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Weight gain
|
5.0%
4/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
Weight loss
|
17.5%
14/80 • Number of events 31 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 36 • 48 months
159 participants were evaluable for adverse events.
|
|
Investigations
White blood cell decreased
|
37.5%
30/80 • Number of events 125 • 48 months
159 participants were evaluable for adverse events.
|
36.7%
29/79 • Number of events 98 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
32/80 • Number of events 56 • 48 months
159 participants were evaluable for adverse events.
|
38.0%
30/79 • Number of events 78 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
3/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
40/80 • Number of events 114 • 48 months
159 participants were evaluable for adverse events.
|
48.1%
38/79 • Number of events 122 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
4/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.8%
3/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
41.2%
33/80 • Number of events 89 • 48 months
159 participants were evaluable for adverse events.
|
46.8%
37/79 • Number of events 94 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.8%
27/80 • Number of events 56 • 48 months
159 participants were evaluable for adverse events.
|
31.6%
25/79 • Number of events 66 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 15 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.2%
25/80 • Number of events 40 • 48 months
159 participants were evaluable for adverse events.
|
32.9%
26/79 • Number of events 46 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.5%
14/80 • Number of events 33 • 48 months
159 participants were evaluable for adverse events.
|
16.5%
13/79 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
24/80 • Number of events 63 • 48 months
159 participants were evaluable for adverse events.
|
32.9%
26/79 • Number of events 48 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.5%
14/80 • Number of events 16 • 48 months
159 participants were evaluable for adverse events.
|
13.9%
11/79 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
3.8%
3/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 19 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.2%
13/80 • Number of events 26 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
4/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
12/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
20.3%
16/79 • Number of events 26 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
3/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
27.5%
22/80 • Number of events 39 • 48 months
159 participants were evaluable for adverse events.
|
17.7%
14/79 • Number of events 40 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
10.0%
8/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
7/80 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
10/80 • Number of events 18 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Arachnoiditis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Cognitive disturbance
|
1.2%
1/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Dizziness
|
16.2%
13/80 • Number of events 22 • 48 months
159 participants were evaluable for adverse events.
|
27.8%
22/79 • Number of events 37 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
3.8%
3/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 13 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Headache
|
18.8%
15/80 • Number of events 22 • 48 months
159 participants were evaluable for adverse events.
|
27.8%
22/79 • Number of events 30 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Lethargy
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.2%
5/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
24.1%
19/79 • Number of events 60 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Seizure
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Sinus pain
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Somnolence
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Stroke
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Syncope
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
|
Nervous system disorders
Tremor
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Agitation
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Anxiety
|
11.2%
9/80 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 15 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Confusion
|
10.0%
8/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
8.9%
7/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Depression
|
16.2%
13/80 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
11.4%
9/79 • Number of events 24 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Hallucinations
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Insomnia
|
18.8%
15/80 • Number of events 32 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 23 • 48 months
159 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
7.5%
6/80 • Number of events 14 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 28 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Hematuria
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.0%
4/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal calculi
|
1.2%
1/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
3.8%
3/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary urgency
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Breast pain
|
1.2%
1/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Penile pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Vaginal pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
5/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.0%
28/80 • Number of events 45 • 48 months
159 participants were evaluable for adverse events.
|
20.3%
16/79 • Number of events 36 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
40/80 • Number of events 75 • 48 months
159 participants were evaluable for adverse events.
|
41.8%
33/79 • Number of events 63 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.8%
7/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
5.1%
4/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal hemorrhage
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.8%
7/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.5%
6/80 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.5%
6/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 8 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
12.5%
10/80 • Number of events 21 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
8/80 • Number of events 10 • 48 months
159 participants were evaluable for adverse events.
|
10.1%
8/79 • Number of events 11 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
2/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.2%
5/80 • Number of events 6 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.5%
2/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
4/80 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
6.3%
5/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
7.5%
6/80 • Number of events 7 • 48 months
159 participants were evaluable for adverse events.
|
7.6%
6/79 • Number of events 9 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
31.2%
25/80 • Number of events 35 • 48 months
159 participants were evaluable for adverse events.
|
26.6%
21/79 • Number of events 32 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/80 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
20.0%
16/80 • Number of events 29 • 48 months
159 participants were evaluable for adverse events.
|
20.3%
16/79 • Number of events 25 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
1.2%
1/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Flushing
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hematoma
|
5.0%
4/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
2.5%
2/79 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypertension
|
13.8%
11/80 • Number of events 21 • 48 months
159 participants were evaluable for adverse events.
|
15.2%
12/79 • Number of events 17 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypotension
|
20.0%
16/80 • Number of events 20 • 48 months
159 participants were evaluable for adverse events.
|
32.9%
26/79 • Number of events 41 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Phlebitis
|
3.8%
3/80 • Number of events 3 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.5%
2/80 • Number of events 2 • 48 months
159 participants were evaluable for adverse events.
|
1.3%
1/79 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
6.2%
5/80 • Number of events 5 • 48 months
159 participants were evaluable for adverse events.
|
3.8%
3/79 • Number of events 4 • 48 months
159 participants were evaluable for adverse events.
|
|
Vascular disorders
Vascular disorders - Other
|
1.2%
1/80 • Number of events 1 • 48 months
159 participants were evaluable for adverse events.
|
0.00%
0/79 • 48 months
159 participants were evaluable for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60